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    Overview of analytical development services from method development & validation to process development & optimization offered by service providers.

    Famar Analytical Method Development & Validation
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    09 Aizant Drug Research Solutions Pvt. Ltd.

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    14 Angelini Pharma

    15 Appcure Labs

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    18 Arevipharma

    19 Ascent Innovative Medicines

    20 Ash Stevens, Inc.

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    25 Basic Pharma

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    28 Bioplus Life Sciences

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    32 Boston Analytical

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    36 Cayman Chemical Company Inc

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    40 Chromcore Lifesciences

    41 Crenza Pharma

    42 Curia

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    44 Curtis Health Caps

    45 Cyndea Pharma S.L

    46 DPT Laboratories, Ltd

    47 Dishman Carbogen Amcis

    48 Doctor's Analytical Laboratories

    49 Etico Lifesciences

    50 Eurofins BioPharma Services

    51 Eurofins CDMO

    52 Evotec

    53 Famar

    54 Fermion Oy

    55 Flagship Biotech International Pvt. Ltd

    56 Fresenius SE & Co. KGaA

    57 FumoPrep

    58 GALIEN LPS

    59 GRAM Laboratory Inc

    60 Globela Pharma

    61 JGL d.d

    62 Kantisto BV

    63 KriSan Biotech

    64 Labiana Life Sciences S.A

    65 Lamda Laboratories

    66 Lonza Capsugel

    67 M2i Group

    68 Madras Pharmaceuticals

    69 Maithili Life Sciences

    70 Megsan Labs Private Limited

    71 Menadiona

    72 Merck Millipore

    73 Mikart

    74 Mission | CDMO

    75 Mithra CDMO

    76 Nanjing Dorra Pharmaceutical Technology Co.,Ltd

    77 Neopharm Labs Inc

    78 NorthEast BioAnalytical Laboratories

    79 Novick Biosciences

    80 Nutrasource

    81 ORIT LABS LLC

    82 Olive Healthcare

    83 Oncomed Manufacturing A.S

    84 Onyx Scientific

    85 Ortiv-Q3 Research

    86 Osmopharm

    87 PCI Pharma Services

    88 PSR Pharma Science and Research

    89 PYRAMID Laboratories, Inc

    90 Pfanstiehl

    91 PharmaVize NV

    92 Prague Scientific

    93 Primera Analytical Solutions Corp

    94 Progenerics Pharma Pvt Ltd

    95 Provepharm Life Solutions

    96 Proveris Scientific

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    98 Quantex Laboratories

    99 Quotient Sciences

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    102 Recipharm AB

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    Overview of analytical development services from method development & validation to process development & optimization offered by service providers.

    Q1. What are analytical development services?

    Analytical research and pharmaceutical development services include method development & validation, stability and degradation studies of APIs and other drugs, and preparation of technical dossiers for registration.

    Pharmaceutical analytical techniques deal with different processes to identify or quantify a substance; the components of a pharmaceutical solution or mixture or the determination of the structures of chemical compounds used in the formulation of pharmaceutical products.

    When existing compounds are used together in a new formulation, analytical method development services may be necessary in order to test the drugs’ interactions with each other, the formulation excipients or biological fluids. 

    Furthermore, drug substances and drug products may develop impurities at various stages of pharmaceutical development, transportation and storage which makes the pharmaceutical products risky to be administered. Therefore, these impurities must be detected and quantified via analytical testing methods. 

    From early candidate analysis to New Drug Application (NDA) or ANDA submission, analytical development services are applicable throughout a drug products development and production cycle. Robust GMP analytical testing methods are available for raw materials, in-process tests, drug substances, APIs / impurities as well as drug product development.

    Analytical services normally included in the pharmaceutical industry, include: pharmaceutical development services and validation of stability indicating analytical methods, supply and execution of method transfer protocols, establishment of new product assay and degradation methods, graduated validation plans to suit the phase of drug development, cleaning validation, report writing and stability studies according to ICH. 

    Some other analytical development services are noted below:

    - Compendial Analytical Testing (USP, EP, JP, BP)

    - Raw Material Analytical Testing

    - QP Release Testing

    - Finished Product GMP Analytical Testing Methods

    - Pharmaceutical Method Development and Validation

    - Method Validation (ICH)

    - Microbiological Analytical Testing Methods

    Furthermore, pharmaceutical analysis contract services can play an important role in pharmaceutical development processes and GMP manufacturing of drug substances. Whether you need help with program specific method development or analytical testing, there are many companies that provide analytical development services using HPLC, LCMS or any number of immunoassays.

    Analytical method development and validation is one of the leading strategies included in a contract providers analytical development services portfolio. Analytical method development and validation services are continuous and interconnected activities conducted throughout the drug development process. These activities are explored in detail in the subsequent question. 

    Q2. What is analytical method development and validation?

    Analytical methods are intended to establish the identity, purity, physical characteristics and potency of drugs. Methods are developed to support drug testing against specifications during manufacturing and quality release operations, as well as long-term stability studies. Methods may also support safety and characterization studies or evaluations of drug performance.

    Biopharmaceutical analytical method development and validation services are also critical to pharmaceutical development and achieving the reliable analytical data you need to reach your next development milestone. Furthermore, analytical method development and validation services play important roles in the discovery, development, and manufacture of pharmaceuticals.

    Analytical Method Development Services

    Analytical method development is the process of selecting an accurate assay procedure to determine the composition of a formulation. Effective analytical method development services ensure that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development. 

    Approved methods establish clear limitations of application and verify that the process is resilient enough so that slight variations between operators or between laboratories do not have a material impact on results.

    Analytical Method Validation

    Method validation, as required by regulatory agencies at certain stages of the drug approval process, is defined as the process of demonstrating that analytical procedures are suitable for their intended use.

    Analytical validation can be defined as the collection and evaluation of data generated from the process/method used during drug product development, whether it is commercial, experimental or a scientific study.

    Any analytic methods one chooses for pharmaceutical method development need to be validated to ensure they’re scientifically sound. Validation ensures any analytic methods you’re using are measuring the substances in your product in the appropriate ranges. Therefore, biopharmaceutical analytical method development and validation services are important for product development and qualifying drug formulation processes.

    Analytical Development and Validation Services include:

    - Pharmaceutical method development for HPLC (HIC, SEC, PLRP), icIEF, CE-SDS, SDS-PAGE, ELISA, cell-based assays, and cleaning methods

    - Qualification/Validation or transfer of methods

    - Drug substance and drug product stability indicating assays

    - Related substances, chiral purity, elemental impurity, and residual solvent analysis

    - Remedial method validation/method lifecycle evaluation studies

    - Preservative and stabilizing excipients assays

    - Process validation support

    - Extractables and leachables studies

    - Method transfer

    - Analytical method development services

    - Specification pharmaceutical development services

    - Reference standard qualification 

    - cGMP support for manufacturing

    Q3.What is process development and optimization?

    Process Development

    Pharmaceutical process development encompasses all essential aspects of the drug formulation process from route and reagent selection to manufacture of the active compound. Drug formulation process development refers to the exercise of creating a route to manufacture a given drug product in a given quantity. It involves the selection and sequencing of process steps from a repertoire of unit operations.

    Regulatory authorities expect product and process development to be based on sound scientific methods and principles, in combination with risk management tools which are applied throughout the development process. Drug formulation process development is completed prior to manufacturing APIs, generics, and biologics. Process development, process engineering and technology transfer teams work together to deliver quality products to consumers. 

    The product and process development team outlines the large scale manufacturing strategy, process engineering teams provide troubleshooting services as required, and finally technology transfer teams take the process from lab to commercial scale. The processes for manufacture of the bulk formulation and of the final dosage form are designed to optimize scale up and technology transfer activities.

    Pharmaceutical Process Development Services for Drug Substances:

    - Technology transfer

    - Lab-scale process evaluation

    - Product and process development 

    - Parametric studies (DoE) 

    - Pilot scale engineering runs.

    Process Optimization

    For delivering quality pharmaceutical products it is important to optimize product development and manufacturing activities. Process optimization can aid product development by providing a framework for process improvement. 

    Process optimization encompasses widely varying activities whose principal goal is to reduce costs by eliminating process steps, improving yields, shortening cycle times and producing higher-quality products. Companies with limited manufacturing capacity must look inside their manufacturing and logistic operations to squeeze more product from existing assets.

    The key to a successful process optimization project lies in the expertise of the scientists and engineers doing the investigative work. There are no rules regarding process optimization when it comes to FDA compliance, other than the requirement that you have a reproducible process in place, and that you are following it each time.

    Steps Involved in Process Optimization Includes:

    - Defining the target product profile (quality, safety, efficacy, bioavailability, stability, etc.)

    - Determining quality of active ingredients and excipients, and subsequently selecting the types and amounts required. 

    - Selecting an appropriate manufacturing process

    - Identifying control strategies. 

    Process Optimization Services:

    - Lab-scale GMP analytical testing methods for raw materials and products 

    - Development of a new manufacturing/processing line or making changes to an existing one

    - Troubleshooting

    - Raw material/component acceptance testing

    - Validation of new material supplies

    - Scale up of a technology

    Q4. Who are the leading analytical development service providers?

    There are various companies offering analytical development services including analytical method development services, validation services, program specific method development, process development & optimization and other biopharmaceutical analytical method development and validation services.

    Proveris Scientific 

    Proveris Scientific can help every step of the way from formulation & device screening, and method development to regulatory submission & out of specification (OOS) investigations for orally inhaled and nasal drug products (OINDPs).

    Proveris offers full method development and analytical services for all spray characterization tests—spray pattern, plume geometry and DSD. Proveris-certified methods can be transferred through all stages of the development cycle from early development through manufacturing QC.

    Skyepharma 

    Full-service CDMO Skyepharma Production S.A.S. (Skyepharma) offers analytical support services in all stages of product development and manufacturing. These services include analytical development and quality control of packaging items, raw materials, finished products (chemical and microbiological analysis) based on European and US regulations.

    At skyepharma product development is closely supported by an experienced analytical team during every phase of the development process. They are able to develop analytical methods in a limited time, from bibliography study, screening parameters and conditions to sample preparation and assessment of robustness.

    ChemWerth Inc

    Through exclusive development and partnerships with API manufacturers, ChemWerth provides expertise in product selection & development; analytical and regulatory services and strong project management to ensure the highest standards of quality.

    Through ChemWerth’s own laboratory, they can provide analytical support services from program specific method development to methods validation. All projects are conducted under cGMP conditions and are supported with DMF filings or product registration.

    ZCL Chemicals 

    ZCL has an analytical development laboratory that provides analytical support services to their synthesis group. Major activities include: Analytical method development & validation for RM, WIP & finished products, OVI method development & method validation, impurity profile studies, etc.

    Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights at ZCL Chemicals.

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    Famar offers analytical method development and validation for drug substances, drug products, impurities, related substances & preservatives. Its analytical development services also include validation of microbiological methods and ICH stability studies.

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    Skyepharma offers various analytical services like method development & validation, process optimization & continuous process monitoring. It also develops analytical methods in a limited amount of time, from bibliography studies to screening parameters.

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    Bachem has extensive analytical expertise and offers all analytical services to ensure successful product development. Its GMP-compliant analytical capabilities include method development and validation, stability studies, nitrosamine determination, etc.

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    Quotient Sciences provides the best analytical support, delivering phase-appropriate method development and validation, candidate screening and drug product analysis.

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    Employing multiple chemical testing methods, we perform qualitative/quantitative analysis, purification, & characterization of chemical entities such as natural products, synthetic compounds, cosmetics, pharmaceuticals, & drugs of abuse from organic & biological matrices.

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    Zach System offers analytical development (UV/CAD/RID-HPLC, GC, HS-GC), structural characterization (GC-MS, HPLC- MS, NMR, IR), etc.

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    Century Pharmaceuticals undertakes contracts for analytical method development of active pharmaceutical ingredients and biotechnology products.

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    Fermion offers the development of analytical methods for SMs, IMs & APIs for Phase I, II & III together with the validation of API analytical methods.

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    Mission CDMO provides a full spectrum of analytical services from method development to finished product release & stability testing. It also offers method transfer, cleaning validation, in-process, and release testing, USP/NF testing, etc.

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    Aspen API has analytical development laboratories that enable them to rapidly solve analytical challenges and offers a variety of analytical method development & subsequent validation, method transfer, ICH stability studies, etc.

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    M2i offers development of analytical methods, complete development of synthetic route & implementation, scale-up, process industrialization, technical batch production and multi-ton GMP production.

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    Mikart offers various analytical services such as analytical method development & validation, method transfer, cleaning validation studies, drug release profiles, etc.

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    Bora offers comprehensive analytical method development services. Its analytical development team develops custom analytical solutions and has a proven track record in small-molecule method development.

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    Sharp offers clinical trial services and develops analytical methods used throughout various phases of their clients’ drug development and manufacturing projects.

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    Seqens offers standalone analytical services including method development​ and validation, and method qualification. It has a proven track record of full development and validation studies, optimization of existing methods & transfer of validated methods.

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    Prague Scientific offers analytical method development, validation and transfer, specification setting, stability and stress testing, CMC and dossier preparation.

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    FumoPrep is an analytical CRO that provides tailored analytical methods for R&D projects in various fields of chemistry, such as purification, formulation, product & process development. It also offers the development of custom methods for UVCB materials.

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      Renejix is a contract development and manufacturing organization that has a wealth of experience in analytical method development such as chiral HPLC & SFC method development. It also has expertise in method optimization, qualification, and validation.

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      Cayman Chemical Company Inc

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      Our contract services group helps companies turn their new drug ideas into reality. Whether for phase I, phase II, phase III, or toxicology studies, we specialize in developing new synthetic routes while providing all necessary support to ensure regulatory compliance.

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      Pharma Service: Analytical

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      Cayman

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      FumoPrep

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      ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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      FumoPrep is an analytical CRO that develops and validates analytical methods for single and multicomponent (even UVCB) test items in a wide range of concentrations and matrices. The studies are conducted in accordance with the relevant GLP regulations.

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      Pharma Service: Analytical

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      Analytical Method Development & Validation

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      Renejix

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        IMPURITY ISOLATION

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        Renejix is a contract development and manufacturing organization that offers analytical method development services such as impurity isolation and identification. It also has expertise in method transfer, optimization, qualification, and validation.

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        Pharma Service: Analytical

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        Impurity Isolation

        Swiss Biotech Day

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        Renejix

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          Renejix is a contract development and manufacturing organization that offers analytical method development and validation services. It also has experience in method transfer, optimization, qualification, and chiral HPLC & SFC method development.

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          Pharma Service: Analytical

          Category: Analytical Method Development

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          Analytical Method Development & Validation

          Swiss Biotech Day

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          Renejix

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            ANALYTICAL METHOD DEVELOPMENT

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            Renejix is a CDMO that offers analytical services such as analytical method transfer, method development and validation, method optimization, method qualification, and chiral HPLC & SFC method development.

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            Pharma Service: Analytical

            Category: Analytical Method Development

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            Analytical Method Development

            Swiss Biotech Day

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            Renejix

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              PREPARATIVE RESOLUTION PROCESSES

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              Renejix is a CDMO that offers analytical method development services such as preparative resolution processes, method validation, impurity isolation, and identification & chiral HPLC & SFC method development.

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              Pharma Service: Analytical

              Category: Analytical Method Development

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              Preparative Resolution Processes

              Swiss Biotech Day

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              Renejix

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                REFERENCE SUBSTANCES & QUALIFICATION

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                Renejix is a CDMO that offers analytical method development services such as reference substances and qualification, preparative resolution processes, method validation, impurity isolation and identification.

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                Pharma Service: Analytical

                Category: Analytical Method Development

                Sub Category: Reference Substances / Qualification

                Reference Substances & Qualification

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                Societal CDMO

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                ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                Recro provides diverse analytical services such as method development and validation (assay, impurities, dissolution and cleaning) and other testing services to assess compound quality.

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                Pharma Service: Analytical

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                Quantex Laboratories

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                  METHOD DEVELOPMENT & VALIDATION

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                  Quantex Laboratories provides cost effective outsourced cGMP and GLP laboratory services to industry. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care producuts, and raw materials.

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                  Pharma Service: Analytical

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                  Sai Life Sciences Limited

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                  ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                  Sai Life Sciences offers analytical method development & validations for NCEs. Structure identification & confirmation of impurities is integral part of the analytical method development.

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                  Pharma Service: Analytical

                  Category: Analytical Method Development

                  Sub Category: Method Development and Validation
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                  Anacipher

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                    ANALYTICAL METHOD VALIDATION STUDIES

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                    We undertake method validation studies as per ICH guidelines. This includes analytical method validation of compendial and non compendial chromatographic method. We also undertake project for analytical method development and validation for cleaning procedures.

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                    Pharma Service: Analytical

                    Category: Analytical Method Development

                    Sub Category: Method Development and Validation
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                    KriSan Biotech

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                      ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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                      KriSan Biotech has extensive experience in analytical method development and validation, analytical research on raw materials, intermediates and active pharmaceutical ingredients (APIs).

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                      Vitas Analytical Services

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                        METHOD DEVELOPMENT, OPTIMIZATION & VALIDATION

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                        Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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                        Pharma Service: Analytical

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                        Solara Active Pharma Sciences

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                        ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                        Solara, Contract Research and Manufacturing Services (CRAMS) provider has a range of experience from 5 to 30 years in analytical services. They provide extensive analytical method development, qualification and validation capabilities.

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                        Pharma Service: Analytical

                        Category: Analytical Method Development

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                        Madras Pharmaceuticals

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                        ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                        Madras Pharma's analytical development capabilities include development & validation of various analytical testing procedures, content uniformity, dissolution, related substances, residual solvents, other in-house test procedures, etc.

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                        Pharma Service: Analytical

                        Category: Analytical Method Development

                        Sub Category: Method Development and Validation
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                        Angelini Pharma

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                        ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                        Angelini has custom development and manufacturing capabilities including analytical development and validation, manufacturing pilot, pre-validation, validation and commercial batches, ICH stability studies, safety and toxicology assessments, etc.

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                        Pharma Service: Analytical

                        Category: Analytical Method Development

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                        Menadiona

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                        ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                        Menadiona offers process development and validation of analytical methods, feasibility evaluations, pilot plant batches, validation batches, regulatory support and commercial production for APIs and advanced intermediates.

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                        Pharma Service: Analytical

                        Category: Analytical Method Development

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                        Fresenius SE & Co. KGaA

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                        DEVELOP & VALIDATE NEW ANALYTICAL METHODS

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                        We provide full QC support - physical, chemical, and microbiological - for starting materials, finished products, and in-process control. In-house expertise is available to develop and validate new analytical methods and to import and modify existing methods.

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                        Pharma Service: Analytical

                        Category: Analytical Method Development

                        Sub Category: Method Development and Validation
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                        Bioplus Life Sciences

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                        ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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                        BioPlus Life Sciences has analytical expertise in method development and validation, scalability study, multimedia dissolution profiles, elemental impurity study, active sourcing and residual solvents testing.

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                        Pharma Service: Analytical

                        Category: Analytical Method Development

                        Sub Category: Method Development and Validation
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                        Curia

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                        METHOD DEVELOPMENT & VALIDATION

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                        Curia's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer covering procedures for APIs, formulations, cosmetics, raw materials, etc.

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                        Pharma Service: Analytical

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                        Acceleration Laboratory Services

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                        ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                        Acceleration Laboratory Services is the foremost contract solutions provider for pharmaceutical research. Their ultimate goal is to deliver superior solutions to clients, on time, and on point, while maintaining a fun and empowering work environment.

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                        Pharma Service: Analytical

                        Category: Analytical Method Development

                        Sub Category: Method Development and Validation
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                        Boston Analytical

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                          METHOD DEVELOPMENT & VALIDATION

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                          Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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                          Pharma Service: Analytical

                          Category: Analytical Method Development

                          Sub Category: Method Development and Validation
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                          Admix Pharma Laboratories, LLC

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                            ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                            With Admix Pharma Laboratories, LLC you will enjoy a host of attractive benefits that can effectively extend your in-house pharmaceutical products development and manufacturing capabilities for long and short term projects.

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                            Pharma Service: Analytical

                            Category: Analytical Method Development

                            Sub Category: Method Development and Validation
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                            Arbro Pharmaceuticals Pvt. Ltd

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                              IMPURITIES AND RELATED SUBSTANCES

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                              Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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                              Pharma Service: Analytical

                              Category: Analytical Method Development

                              Sub Category: Impurity Isolation and Identification
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                              GALIEN LPS

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                              OPTIMIZATION, MODERNIZATION & VALIDATION OF METHODS

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                              Galien LPS offers analytical services which covers: Stability studies ICH and On-going; Analyses of raw materials and finished products; Optimization and modernization of methods , HPLC to UPLC transposition ; Validation; Reports, trend analysis.

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                              Pharma Service: Analytical

                              Category: Analytical Method Development

                              Sub Category: Method Development and Validation
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                              JGL d.d

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                              ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                              JGL’s laboratories are equipped for development and validation of analytical methods, preformulation testing, formulation development and technological process optimization.

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                              Pharma Service: Analytical

                              Category: Analytical Method Development

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                              Acceleration Laboratory Services

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                              IMPURITIES ASSAY

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                              Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

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                              Pharma Service: Analytical

                              Category: Analytical Method Development

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                              mKnal Global Solutions

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                                ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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                                Category: Analytical Method Development

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                                UQUIFA

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                                ANALYTICAL METHOD VALIDATION

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                                Uquifa has capabilities for analytical method validation, stability studies, process validation, working standard supply, scale up to commercial, process transfer, etc.

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                                Pharma Service: Analytical

                                Category: Analytical Method Development

                                Sub Category: Method Development and Validation
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                                Nutrasource

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                                  FORMULATION VALIDATION SUPPORT TESTING

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                                  Our product analytics division offers full analytical testing services to ensure your products and ingredients comply with regulatory requirements for quality and purity.

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                                  Category: Analytical Method Development

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                                  Proveris Scientific

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                                    METHOD DEVELOPMENT FOR NASAL DRUG PRODUCTS

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                                    Proveris offers services from formulation and device screening, method development, through-life product testing, to regulatory submission, quality release, and out of specification (OOS) investigations for orally inhaled and nasal drug products (OINDPs).

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                                    Category: Analytical Method Development

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                                    Primera Analytical Solutions Corp

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                                    CHIRAL SEPARATION

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                                    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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                                    Pharma Service: Analytical

                                    Category: Analytical Method Development

                                    Sub Category: Chiral HPLC & SFC Method Development
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                                    Merck Millipore

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                                      BIORELIANCE® VALIDATION SERVICES

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                                      Accelerate and simplify your path to market by letting our BioReliance® Validation Services help you select, test and validate the filters, assemblies and single-use systems for drug manufacturing processing.

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                                      Crenza Pharma

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                                        ANALYTICAL DEVELOPMENT

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                                        Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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                                        Category: Analytical Method Development

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                                        Primera Analytical Solutions Corp

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                                        DRUG SUBSTANCE IMPURITY PROFILES

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                                        Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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                                        Pharma Service: Analytical

                                        Category: Analytical Method Development

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                                        Bio-Technology General Israel Ltd.

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                                          BIOPHARMACEUTICAL ANALYTICAL DEVELOPMENT

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                                          Our 1,700 square meter development laboratories and pilot plants are active in: Protein purification.

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                                          Tepnel Pharma Services

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                                            ICH Q2 (R1) & cGMP COMPLIANT METHOD DEVELOPMENT & VALID...

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                                            Tepnel performs analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.

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                                            Crenza Pharma

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                                              CCIT METHOD DEVELOPMENT & VALIDATION

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                                              Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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                                              PSR Pharma Science and Research

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                                                ANALYTICAL METHOD DEVELOPMENT & VALIDATIONS

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                                                PSR has necessary expertise & access to advanced technologies to develop the formulation and also, through the use of targeted analytics, supply the client with the relevant information needed to aid in the correct selection of formulation/drug delivery system to meet the clients requirements.

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                                                Sushen Medicamentos Pvt. Ltd

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                                                  ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                  SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

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                                                  Acceleration Laboratory Services

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                                                  REFERENCE STANDARD QUALIFICATION

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                                                  Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

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                                                  Vitas Analytical Services

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                                                    IMPURITY PROFILING METHODS

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                                                    Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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                                                    Neopharm Labs Inc

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                                                      IDENTIFICATION OF IMPURITIES WITH LC-MS (Q-TOF) AND GC-...

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                                                      Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

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                                                      QUINTA-ANALYTICA s.r.o

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                                                      METHOD TRANSFER & VALIDATION

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                                                      Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

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                                                      Ash Stevens, Inc.

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                                                      METHODS DEVELOPMENT & METHODS VALIDATION

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                                                      Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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                                                      Boston Analytical

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                                                        ASSAY & PURITY TESTING OF PRODUCTS

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                                                        Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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                                                        Anacipher

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                                                          CHIRAL METHOD DEVELOPMENT

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                                                          We undertake development of critical parameters or methods, such as analytical method to determine impurities, which don't have chromophores and hence don't have detection, Chiral method development, LC-MS suitable method development.

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                                                          Vitas Analytical Services

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                                                            REFERENCE STANDARD CHARACTERIZATION

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                                                            Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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                                                            BirgiMefar Group

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                                                            ANALYTICAL METHOD VALIDATIONS

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                                                            Stability studies & Analytical Method Validations & Process Validation Scale-up batch production.

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                                                            CLEARSYNTH LABS LIMITED

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                                                              ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                              CLEARSYNTH team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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                                                              ACTA Laboratories Inc

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                                                                cGMP METHOD VALIDATION & DEVELOPMENT

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                                                                ACTA performs cGMP method validation in accordance with USP and ICH requirements. Parameters normally validated are accuracy, precision, specificity, limit of detection, limit of quantitation, linearity, range and robustness. ACTA’s staff is highly experienced with method development for

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                                                                Mithra CDMO

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                                                                DEVELOPMENT & VALIDATION OF DIFFUSION PROFILES

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                                                                By Complying major guidelines and pharmacopeias (ICH, EMA, FDA, USP, EP), Our mission is to develop and validate reliable methods analytical methods for drug substances, excipients, drug products, raw materials and cleaning methods and diffusion profiles adapted to formulation.

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                                                                Santa S.A

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                                                                  ANALYTICAL DEVELOPMENT, VALIDATION & TRANSFER

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                                                                  We offer full service solutions and project management for cost effective product development in pharmaceutical as well as food /nutraceutical areas.

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                                                                  Quantex Laboratories

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                                                                    PHARMACEUTICAL METHOD DEVELOPMENT AND VALIDATION OF PRO...

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                                                                    Our laboratory has 25 years of in depth experience with designing and executing method development and validation, verification and method transfer protocols and experiments.

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                                                                    Oncomed Manufacturing A.S

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                                                                    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                    Oncomed offers end-to-end solutions covering the whole lifecycle of products with a focus on contract services including analytical method development & validation, development, material and final product release, etc.

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                                                                    Boston Analytical

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                                                                      IMPURITIES / RELATED COMPOUNDS

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                                                                      Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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                                                                      Ash Stevens, Inc.

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                                                                      IMPURITY ISOLATION & IDENTIFICATION (INCLUDING GTIS)

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                                                                      Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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                                                                      Dishman Carbogen Amcis

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                                                                      PROCESS CONTROL & MATERIAL CHARACTERIZATION

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                                                                      Dishman strives to provides analytical services support in both process control and material characterization for laboratory and production chemistry from initial raw material release to release of the final APIs.

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                                                                      Quantex Laboratories

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                                                                        IDENTIFICATION & QUALIFICATION OF IMPURITIES OR DEGRADA...

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                                                                        Quantex Laboratories offers comprehensive impurities testing for both small and large molecule drug products and medical devices.

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                                                                        ORIT LABS LLC

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                                                                        ANALYTICAL CAPABILITIES- METHODS VALIDATION & TRANSFER

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                                                                        Orit Laboratories comprises of analytical testing laboratories and formulation development areas operating under cGLP and cGMP. Orit has a number of products already approved and marketed, with several additional products already filed and under FDA review.

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                                                                        mKnal Global Solutions

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                                                                          IMPURITY SYNTHESIS, ISOLATION AND CHARACTERIZATION

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                                                                          Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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                                                                          Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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                                                                            ANALYTICAL METHOD DEVELOPMENT & QUALIFICATION

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                                                                            Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

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                                                                            Nutrasource

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                                                                              ANALYTICAL METHOD DEVELOPMENT

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                                                                              Our in-house laboratory, Diteba, offers analytical services in:Method development, validation and method transfer for Potency assay, Related substances (impurities), Dissolution methods; Forced degradation studies; and Cleaning validation testing.

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                                                                              GRAM Laboratory Inc

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                                                                                QUALIFICATION OF API IMPURITY PROFILE

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                                                                                GRAM Laboratories provides services geared towards qualification of an active pharmaceutical ingredient, through monograph testing, compendial and vendor method verification, qualification of impurity profile, independent verification of vendor’s certificate of analysis.

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                                                                                APC Ltd

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                                                                                  ANALYTICAL METHOD DEVELOPMENT

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                                                                                  Full method development and optimization based on client’s specific needs such as TCID50, qPCR, FACS, HCDNA/HCP determination, osmolality, pH conductivity, microscopy.

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                                                                                  QUINTA-ANALYTICA s.r.o

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                                                                                  LC / MS & GC / MS METHODS FOR TRACE ANALYSIS

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                                                                                  We are skilled in the development of analytical methods for determination of trace amounts of tracked impurities. We usually develop methods for assessment of toxic impurities at levels much below those demanded by corresponding regulatory authorities.

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                                                                                  SEQUENT SCIENTIFIC LTD

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                                                                                  IMPURITY PROFILING

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                                                                                  Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

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                                                                                  CLEARSYNTH LABS LIMITED

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                                                                                    ISOLATION & CHARACTERIZATION OF IMPURITIES

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                                                                                    Clearsynth team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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                                                                                    Etico Lifesciences

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                                                                                      METHOD DEVELOPMENT, VALIDATION & TRANSFERS

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                                                                                      Our cross functional teams at Etico namely are Business Development, Formulation Development, Analytical Development, Development Quality Assurance, Microbiology, Project Management, Regulatory Affairs, IPR management, HR, Finance & IT.

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                                                                                      ZCL Chemicals Limited

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                                                                                      ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                      ZCL has an analytical development laboratory to support their synthesis group. Major activities include: Analytical method development & validation for RM, WIP & finished products, OVI method development & method validation, impurity profile studies, etc.

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                                                                                      Saneca Pharmaceuticals

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                                                                                      Our finished dosage form development team has successfully created numerous control release and extended release formulations, successfully ensuring afterward rapid scale up to full production.

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                                                                                      CLEARSYNTH LABS LIMITED

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                                                                                        RESOLUTION OF CHIRAL COMPOUNDS

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                                                                                        Clearsynth team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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                                                                                        Arevipharma

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                                                                                        DEVELOPS, VALIDATES & TRANSFERS NEW METHODS OF ANALYSIS

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                                                                                        The quality of API manufactured by Arevipharma has sealed their good reputation among customers. Raw materials, intermediates, API and primary packaging are checked in accordance to specification and communicated and professionally documentated in an efficient manner.

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                                                                                        RD Laboratories

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                                                                                          IMPURITIES TESTING

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                                                                                          R.D. Laboratories maintains a large array of analytical instrumentation capable of performing a wide variety of procedures.

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                                                                                          Chemtos

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                                                                                            REFERENCE STANDARDS

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                                                                                            We have a large number of Anaytical Reference Standards available in stock for delivery

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                                                                                            ChemCon GmbH

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                                                                                            ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                            ChemCon has developed and validated analytical methods in-house since 2001. It offers transfer of existing methods & establishment of new methods as per the international monographs, risk assessment of new methods, etc.

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                                                                                            QUINTA-ANALYTICA s.r.o

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                                                                                            ISOLATION OF SELECTED COMPONENTS

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                                                                                            We use either a classical low-pressure column chromatography or HPLC on our automated semi-preparative modular HPLC system (Waters).

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                                                                                            Anacipher

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                                                                                              ANALYTICAL METHOD DEVELOPMENT

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                                                                                              We undertake complete analytical project development activities for formulation as well as API products. This includes analytical method development for RMs, Intermediates, Inprocess and finished product in line with regulatory requirements.

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                                                                                              ZCL Chemicals Limited

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                                                                                              IMPURITY PROFILE STUDIES

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                                                                                              Our highly qualified professionals are working in product development, analytical development & IP rights. Our activities include Route Scouting, Process Development, Scale up, Technology Transfer, Synthesizing Impurities, Contract Research etc

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                                                                                              Solara Active Pharma Sciences

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                                                                                              IMPURITY PROFILING

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                                                                                              Solara's R&D capabilities in synthetic development services, and analytical development services offers impurity profiling and quantification at trace levels (genotoxic impurities in PPB and PPM) using LCMS-MS & GCMS-MS.

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                                                                                              Unither Pharmaceuticals

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                                                                                              ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                              Unither analytical services include method development & validation, analytical method transfer & ICH stability studies. They provide extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc.

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                                                                                              Merck Millipore

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                                                                                                DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS

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                                                                                                Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

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                                                                                                Ash Stevens, Inc.

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                                                                                                REFERENCE STANDARD QUALIFICATION AND MAINTENANCE

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                                                                                                Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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                                                                                                SEQUENT SCIENTIFIC LTD

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                                                                                                REFERENCE STANDARD MANAGEMENT

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                                                                                                Sequent follow ICH guidelines for cost effective standard characterisation with CoA; assure each standard fit for use in method validations/sample analysis/PK studies /product release.

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                                                                                                Neopharm Labs Inc

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                                                                                                  cGMP METHODS DEVELOPMENT & VALIDATION

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                                                                                                  All analyses are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia. Our experienced microbiology team can perform a wide range of compendial assays, including: USP/NF, AAMI, BP/Ph. Eur, AOAC, AWWA, FDA-BAM and Client supplied methods.

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                                                                                                  Dishman Carbogen Amcis

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                                                                                                  METHOD DEVELOPMENT & VALIDATION

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                                                                                                  Dishman's analytical services support both process control and material characterization including method development & validation for laboratory and production chemistry from initial raw material release to release of the final APIs.

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                                                                                                  Sushen Medicamentos Pvt. Ltd

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                                                                                                    SEPARATION & PURIFICATION OF IMPURITIES

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                                                                                                    SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

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                                                                                                    Flagship Biotech International Pvt. Ltd

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                                                                                                    ANALYTICAL DEVELOPMENT

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                                                                                                    Flagship biotech had established A state-of-art Research and Development Centre (R&D) at Mumbai - focused towards developing new products, improving existing products as well as drug delivery systems and expanding product applications.

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                                                                                                    Anacipher

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                                                                                                      IMPURITIES STUDY

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                                                                                                      Impurities of Drug products, API and intermediates can be studied. Impurities and degradation of products can be studied and unknown impurities can be identified by means of LC-MS and LC-MS-MS analysis. Specified impurity contained within the sample can be isolated, purified and identified.

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                                                                                                      Maithili Life Sciences

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                                                                                                        DEVELOPMENT OF RELIABLE ANALYTICAL METHODS

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                                                                                                        Development of reliable analytical methods for in-process control for intermediates and APIs.

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                                                                                                        Progenerics Pharma Pvt Ltd

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                                                                                                          METHOD DEVELOPMENT & VALIDATION

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                                                                                                          We provide full range of analytical services, State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

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                                                                                                          Arbro Pharmaceuticals Pvt. Ltd

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                                                                                                            METHOD VALIDATION

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                                                                                                            Our laboratory has carried out hundreds of method validation studies for leading pharmaceutical companies in India and around the world helping them successfully register their products in various countries.

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                                                                                                            SEQUENT SCIENTIFIC LTD

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                                                                                                            METHOD DEVELOPMENT, VALIDATION & TRANSFER

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                                                                                                            To keep abreast of the industry requirement, we invest in the latest instruments and our laboratory has enough space to undertake client specific requirements for continuous routine or bulk analysis.

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                                                                                                            Progenerics Pharma Pvt Ltd

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                                                                                                              REFERENCE STANDARD CHARACTERIZATION

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                                                                                                              We provide full range of analytical services, State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

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                                                                                                              RD Laboratories

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                                                                                                                DEVELOPING A METHOD FOR THE ANALYSIS OF AN API IN FDF

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                                                                                                                R.D. Laboratories has extensive experience providing both method development and validation services. Most often we are asked to develop a method for the analysis of an active drug substance in a finished product.

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                                                                                                                Arbro Pharmaceuticals Pvt. Ltd

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                                                                                                                  IMPURITY PROFILING METHODS

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                                                                                                                  The team at Arbro undertakes the development of analytical methods using HPLC, GC, AAS, HPTLC, ICP-MS, GCMS, LCMSMS, chemical and microbiological and many other techniques. All methods developed by our lab are fully validated as per the current requirements laid down in the ICH guidelines Q2(R1).

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                                                                                                                  ScinoPharm Taiwan, Ltd

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                                                                                                                  ANALYTIC METHODS DEVELOPMENT & VALIDATION

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                                                                                                                  ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

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                                                                                                                  Ascent Innovative Medicines

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                                                                                                                    ANALYTICAL METHOD DEVELOPMENT

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                                                                                                                    With our vast experience we add exponential value to our client’s R&D programs at every stage of the drug development. We serve as a vital link between the pharmaceutical companies and the healthcare industry.

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                                                                                                                    Zenvision Pharma LLP

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                                                                                                                      METHOD DEVELOPMENT, QUALIFICATION, VALIDATION, TRANSFER

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                                                                                                                      Zenvision has standalone analytical services including complete analytical support for dossier filing.

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                                                                                                                      Adare Pharma Solutions

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                                                                                                                      ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                      Adare Pharma Solutions is a CDMO that provides development capabilities for analytical method development & validation, IMPD manufacturing & QP release, tech transfer, ICH stability programs at all conditions, etc.

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                                                                                                                      Curida AS

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                                                                                                                        IDENTIFICATION OF ACTIVE INGREDIENTS & IMPURITIES

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                                                                                                                        Curida Laboratories have more than 40 years of experience within the pharmaceutical industry. We offer a wide range of quality control testing services to support development of methods, routine testing of raw materials and finished products as well as stability testing.

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                                                                                                                        Anacipher

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                                                                                                                          CHROMATOGRAPHIC METHOD DEVELOPMENT & VALIDATION

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                                                                                                                          We have extensive experience in chromatographic method development and validation including reverse phase, normal phase and Chiral HPLC methods and Head space GC methods. We have expertise in spectroscopic, titrimetric and particle size analysis methods development and method validations.

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                                                                                                                          Curida AS

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                                                                                                                            METHOD DEVELOPMENT & VALIDATION

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                                                                                                                            Curida has an extensive knowledge and expertise in developing? and validating methods for finished products including cleaning validation

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                                                                                                                            Merck Millipore

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                                                                                                                              REFERENCE MATERIALS

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                                                                                                                              Merck offers a range of first-class reference materials for analytical methods under the trade name Certipur®, all of which are traceable to international standards.

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                                                                                                                              Zenvision Pharma LLP

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                                                                                                                                CHIRAL ANALYSIS

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                                                                                                                                Zenvision has standalone analytical services including complete analytical support for dossier filing.

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                                                                                                                                ScinoPharm Taiwan, Ltd

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                                                                                                                                IDENTIFICATION OF IMPURITIES

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                                                                                                                                ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

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                                                                                                                                Sofarimex

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                                                                                                                                  ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                  Sofarimex is the leader manufacturing company of pharmaceutical products in Portugal. This factory has a large productive flexibility, producing several pharmaceutical forms like solids, liquids, semi-solids & sterile products.

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                                                                                                                                  Category: Analytical Method Development

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                                                                                                                                  GRAM Laboratory Inc

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                                                                                                                                    FILTER QUALIFICATION & VALIDATION STUDIES

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                                                                                                                                    GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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                                                                                                                                    Pharma Service: Analytical

                                                                                                                                    Category: Analytical Method Development

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                                                                                                                                    Progenerics Pharma Pvt Ltd

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                                                                                                                                      IMPURITIES

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                                                                                                                                      We provide full range of analytical services, State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

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                                                                                                                                      Ropack Inc

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                                                                                                                                        METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                        Our cGMP lab performs method development and validation for a broad spectrum of pharmaceutical compounds and dosage forms during various drug development stages,

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                                                                                                                                        Category: Analytical Method Development

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                                                                                                                                        Shijiazhuang Rainbowlabs Pharmaceutical Technology

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                                                                                                                                          VERIFICATION OF HPLC ANALYTICAL METHODS

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                                                                                                                                          Rainbowlabs has received the highest accreditation from the U.S. FDA, Health Canada, ISO and CNAS over the past number of years. Rainbowlabs can do analytical method development based on customers requirement.

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                                                                                                                                          PharmaVize NV

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                                                                                                                                            METHOD VALIDATION & TRANSFER ACTIVITIES

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                                                                                                                                            Pharmavize operates an audited 1,600-m2 GMP facility serving clients from all over the world. We are thoroughly familiar with the European and American regulatory frameworks and guarantee compliance with all applicable guidelines and directives.

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                                                                                                                                            Shijiazhuang Rainbowlabs Pharmaceutical Technology

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                                                                                                                                              VERIFICATION OF GC ANALYTICAL METHODS

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                                                                                                                                              Rainbowlabs has received the highest accreditation from the U.S. FDA, Health Canada, ISO and CNAS over the past number of years. Rainbowlabs can do analytical method development based on customers requirement.

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                                                                                                                                              Recipharm AB

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                                                                                                                                              ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                              Recipharm analytical solutions support customers with stand-alone analytical requirements which includes analytical method development & validation, stability program design & analysis, pharmacopeial testing & verification and extractables & leachables.

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                                                                                                                                              Pharma Service: Analytical

                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                              QUINTA-ANALYTICA s.r.o

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                                                                                                                                              CAPILLARY ELECTROPHORESIS METHOD DEVELOPMENT

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                                                                                                                                              Quinta-Analytica operating in full compliance with GCP/GLP/GMP and FDA standards. Quinta offers capillary electrophoresis analytical method development services and capillary electrophoresis method development for pharmacopoeial drugs.

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                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                              Eurofins CDMO

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                                                                                                                                              IMPURITIES ISOLATION & IDENTIFICATION

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                                                                                                                                              Eurofins CDMO offers a complete CMC gap analysis & risk assessment including fate & purge studies & impurities markers synthesis. They offer chromatography for the isolation of process impurities, LC/MS-MS/MS and multi-nuclear NMR for characterization.

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                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                              STABICON LIFE SCIENCE PVT LTD

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                                                                                                                                                ANALYTICAL DEVELOPMENT & VALIDATION

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                                                                                                                                                To ensure successful method development there is a requirement for highly skilled analytical judgement. The 'purpose' of the method needs to be determined with some clarity and thoroughness as this will ultimately determine the long-term success of the new method.

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                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                Catalent Pharma Solutions

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                                                                                                                                                ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                Catalent offers various analytical services including Method Development / Validation / Transfer, Compendial Testing, Microbiology Testing, Structure Characterization, Release & Stability Testing, Specialized Testing, etc.

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                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                QUINTA-ANALYTICA s.r.o

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                                                                                                                                                ANALYTICAL METHOD DEVELOPMENT

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                                                                                                                                                Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

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                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                Aizant Drug Research Solutions Pvt. Ltd.

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                                                                                                                                                METHOD DEVELOPMENT, VALIDATION & TRANSFER

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                                                                                                                                                Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

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                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                Osmopharm

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                                                                                                                                                  ANALYTICAL SERVICES

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                                                                                                                                                  Osmopharm provides analytical services such as analytical and production validations along with other services like stability studies, technical dossier (CTD Format), bulk manufacturing, capsules filling-tabletting, blistering and bottle filling, etc.

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                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                  Category: Analytical Method Development

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                                                                                                                                                  Provepharm Life Solutions

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                                                                                                                                                  ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                  Provepharm offers small molecules design and synthesis with expertise in analytical method development and analytical method validation.

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                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                  Category: Analytical Method Development

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                                                                                                                                                  SIELC Technologies

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                                                                                                                                                    PREPARATIVE CHROMATOGRAPHY METHOD DEVELOPMENT

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                                                                                                                                                    With over 50 years of combined experience in analytical method development, SIELC Technologies helps in preparative chromatography method development and new chromatographic custom phase development.

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                                                                                                                                                    Pharma Service: Analytical

                                                                                                                                                    Category: Analytical Method Development

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                                                                                                                                                    Symbiosis Pharmaceutical Services

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                                                                                                                                                      ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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                                                                                                                                                      Symbiosis Pharma has capabilities to offer analytical method development and validation, analytical method transfer, filter compatibility testing and container closure compatibility testing.

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                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                      Actarmo Medical

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                                                                                                                                                        METHOD DEVELOPMENT FOR NASAL DRUG PRODUCTS

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                                                                                                                                                        Actarmo's analytical services include analytical method development, validation and transfer for inhalation drug products such as DPIs, MDIs, nebulizers, and nasal sprays.

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                                                                                                                                                        Pharma Service: Analytical

                                                                                                                                                        Category: Analytical Method Development

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                                                                                                                                                        Kantisto BV

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                                                                                                                                                          METHOD DEVELOPMENT IN CE

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                                                                                                                                                          Kantisto BV is capillary electrophoresis service provider which offers support in practical and strategic issues through long or short term assignments. It also offers capillary electrophoresis method development for pharmacopoeial drugs.

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                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                          Category: Analytical Method Development

                                                                                                                                                          Sub Category: Capillary Electrophoresis
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                                                                                                                                                          Softigel Procaps

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                                                                                                                                                          ANALYTICAL METHOD DEVELOPMENT & EVALUATION

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                                                                                                                                                          Softigel's pre-clinical & phases I & II services include pre-formulation, formulation development, analytical method development & evaluation, cleaning residure test, CTM lots testing, analytical method development & validation, etc.

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                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                          Category: Analytical Method Development

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                                                                                                                                                          Bellen Chemistry

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                                                                                                                                                            ANALYTICAL METHODS & VALIDATIONS

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                                                                                                                                                            Bellen Chemistry, with experienced teams, state-of-the-art equipment, tools and techniques has over a decade of experiences and successful track records in developing compliant and clinical phase-appropriate analytical methods and validations.

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                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                            Category: Analytical Method Development

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                                                                                                                                                            Megsan Labs Private Limited

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                                                                                                                                                            METHOD DEVELOPMENT & VALIDATIONS

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                                                                                                                                                            Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                            Category: Analytical Method Development

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                                                                                                                                                            Curtis Health Caps

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                                                                                                                                                              ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                              Curtis Health Caps offers various pharmaceutical services such as development & validation of analytical methods, optimization & transfer of analytical methods in accordance with the ICH guidelines, pharmacopoeial & GMP requirements.

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                                                                                                                                                              Pharma Service: Analytical

                                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                                              Doctor's Analytical Laboratories

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                                                                                                                                                                ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                DALPL provides analytical method development and validation services at the pharma division for genotoxic impurity [nitrosamine impurities] quantification studies, carryover impurity studies, elemental impurities, extractable & leachables, etc.

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                                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                                DPT Laboratories, Ltd

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                                                                                                                                                                ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                Analytical method development, assessment and validation for small molecules, peptides and proteins.

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                                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                                Tapemark Company

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                                                                                                                                                                ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                Tapemark's cGMP compliant in-house analytical lab provides full analytical support such as method development, transfer, verification, & validation, final product release testing, ICH stability storage and testing, compendial raw material testing, etc.

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                                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                                Category: Analytical Method Development

                                                                                                                                                                Sub Category: Method Development and Validation
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                                                                                                                                                                NorthEast BioAnalytical Laboratories

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                                                                                                                                                                  BIOANALYTICAL METHOD DEVELOPMENT

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                                                                                                                                                                  Northeast BioLab has expertise in bioanalytical method development which includes setup, optimization, & pre-validation of chromatographic assays or ligand binding assays in chosen biological matrices. It also optimizes assay method for PK & PD analysis.

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                                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                                  Category: Analytical Method Development

                                                                                                                                                                  Sub Category: Biologic Drugs
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                                                                                                                                                                  Solvias

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                                                                                                                                                                  ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                  Solvias has experience in developing analytical methods throughout the entire drug lifecycle. It helps in selecting promising analytical methods and carry out development, validation and transfer within the constraints of GMP and registration deadlines.

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                                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                                  Category: Analytical Method Development

                                                                                                                                                                  Sub Category: Method Development and Validation
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                                                                                                                                                                  Analytical Resource Laboratories

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                                                                                                                                                                    CAPILLARY ELECTROPHORESIS METHOD DEVELOPMENT

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                                                                                                                                                                    EuTech Scientific Services is a capillary electrophoresis service provider. We have been partnering with several CE companies for either developing new products or extending the use of their current products. It also offers capillary electrophoresis method development for pharmacopoeial drugs.

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                                                                                                                                                                    Pharma Service: Analytical

                                                                                                                                                                    Category: Analytical Method Development

                                                                                                                                                                    Sub Category: Capillary Electrophoresis
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                                                                                                                                                                    Evotec

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                                                                                                                                                                    METHOD DEVELOPMENT AND VALIDATION

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                                                                                                                                                                    Evotec scientists are aided by the latest generation software tools, such as DryLab®, Empower™ and Method Validation Manager (MVM) to support both development and validation and to deliver effective solutions for each pharmaceutical development phase

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                                                                                                                                                                    Pharma Service: Analytical

                                                                                                                                                                    Category: Analytical Method Development

                                                                                                                                                                    Sub Category: Method Development and Validation
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                                                                                                                                                                    Avomeen

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                                                                                                                                                                      BIOLOGICAL TESTING SERVICES

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                                                                                                                                                                      Avomeen offers biological testing capabilities which includes PK/PD method development, trace metal analysis, process impurity detection, protein identification services, specific activity method development, etc.

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                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                      Category: Analytical Method Development

                                                                                                                                                                      Sub Category: Biologic Drugs
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                                                                                                                                                                      Bellen Chemistry

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                                                                                                                                                                        METHOD DEVELOPMENT FOR CHIRAL COMPOUNDS

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                                                                                                                                                                        Bellen Chemistry's team has extensive experience in developing methods for chiral compounds, non-chromophoric compounds, and in handling complex sample metrics, high molecular weight substances, structure identification of intermediates & impurities, etc.

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                                                                                                                                                                        Pharma Service: Analytical

                                                                                                                                                                        Category: Analytical Method Development

                                                                                                                                                                        Sub Category: Chiral HPLC & SFC Method Development
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                                                                                                                                                                        Arcinova

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                                                                                                                                                                          ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                          We produce validated analytical methods to reassure clients that data is reliable before moving on to regulatory stages for first-in-human tests. We provide the highest quality method development & validation to support our clients.

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                                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                                          Category: Analytical Method Development

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                                                                                                                                                                          Eurofins BioPharma Services

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                                                                                                                                                                            ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                            Eurofins BioPharma Product Testing network of laboratories can support the development and validation of virtually any test for your starting material, API, bulk product, finished product, intermediate or packaging under cGMP guidelines.

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                                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                                            Category: Analytical Method Development

                                                                                                                                                                            Sub Category: Method Development and Validation
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                                                                                                                                                                            Bluepharma

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                                                                                                                                                                            DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS

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                                                                                                                                                                            The experienced R & D team is also responsible for the development and validation of efficient and sensitive analytical methods.

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                                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                                            Category: Analytical Method Development

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                                                                                                                                                                            Zelmic

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                                                                                                                                                                              ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                              Zelmic's in-house GMP laboratory offers analytical method development services to support the early phase of pharmaceutical formulations. It also provides analytical method verification and validation through GMP batch release testing.

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                                                                                                                                                                              Pharma Service: Analytical

                                                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                                                              Labiana Life Sciences S.A

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                                                                                                                                                                              DEVELOPMENT & VALIDATION OF ANALYTICAL METHOD

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                                                                                                                                                                              In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries and provides development and validation of analytical methods.

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                                                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                                                              Chromcore Lifesciences

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                                                                                                                                                                                METHOD DEVELOPMENT & VALIDATION SERVICES

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                                                                                                                                                                                Chromcore offers various analytical services such as analytical method development & validation, analytical method transfer, analytical method verification, etc.

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                                                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                                                Ortiv-Q3 Research

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                                                                                                                                                                                  ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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                                                                                                                                                                                  Ortiv-Q3 Research is equipped with a wide range of state-of-the-art instrumentation capabilities for developing & validating analytical methods. It also provides analytical method automation, physiochemical Q3 characterization, and IVRT services.

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                                                                                                                                                                                  Category: Analytical Method Development

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                                                                                                                                                                                  Bellen Chemistry

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                                                                                                                                                                                    ANALYTICAL METHOD DEVELOPMENT

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                                                                                                                                                                                    Bellen Chemistry provides various development services such as analytical method development, commercial route development and scale-up, process control strategy for RSM, intermediates and APIs, process validation & safety assessment, etc.

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                                                                                                                                                                                    Pharma Service: Analytical

                                                                                                                                                                                    Category: Analytical Method Development

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                                                                                                                                                                                    Sterin Labs

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                                                                                                                                                                                      ANALYTICAL METHOD DEVELOPMENT SERVICES

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                                                                                                                                                                                      Sterin's analytical method development services include solid state characterization, cleaning method, method transfer, validation, & ICH stability studies. It offers HPLCs, GC, UV-Visible spectrophotometry, water activity, moisture quantification, etc.

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                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                                                      ARx

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                                                                                                                                                                                      ARx supports global partnerships with various project capabilities including analytical method development & validation, analytical testing for method development, transfer, verification, validation, and final product release.

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                                                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                                                      Almelo

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                                                                                                                                                                                        DEVELOPMENT OF ANALYTICAL METHODS

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                                                                                                                                                                                        The Almelo Research Center (ARC) is a fully established facility for our in-house and custom product R&D services.

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                                                                                                                                                                                        Pharma Service: Analytical

                                                                                                                                                                                        Category: Analytical Method Development

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                                                                                                                                                                                        Labiana Life Sciences S.A

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                                                                                                                                                                                        CHARACTERIZATION OF THE IMPURITY PROFILE

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                                                                                                                                                                                        In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries and provides study of solubility in different media.

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                                                                                                                                                                                        Pharma Service: Analytical

                                                                                                                                                                                        Category: Analytical Method Development

                                                                                                                                                                                        Sub Category: Impurity Isolation and Identification
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                                                                                                                                                                                        AES Life Sciences

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                                                                                                                                                                                          METHOD DEVELOPMENT FOR BIOSIMILARS USING CIF

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                                                                                                                                                                                          AES is a capillary electrophoresis service provider, It is dedicated for providing protein separation, quantification, and characterization. It also offers capillary electrophoresis method development for biosimilars.

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                                                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                                                          Category: Analytical Method Development

                                                                                                                                                                                          Sub Category: Capillary Electrophoresis
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                                                                                                                                                                                          Lonza Capsugel

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                                                                                                                                                                                          PRODUCT DEVELOPMENT AND CUSTOMIZATION

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                                                                                                                                                                                          Capsugel® capsules are highly customizable solutions based on precision product design and deep technology expertise that offer pharmaceutical customers increased speed to market and commercial success rate, even with challenging compounds.

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                                                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                                                          Category: Analytical Method Development

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                                                                                                                                                                                          SGS Life Sciences

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                                                                                                                                                                                          METHOD DEVELOPMENT, OPTIMIZATION & VALIDATION

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                                                                                                                                                                                          We are able to serve pharmaceutical and biopharmaceutical companies of all sizes with a range of tests for drug development at both pre- clinical and clinical stages from early to late phase.

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                                                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                                                          Category: Analytical Method Development

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                                                                                                                                                                                          Cambrex Corporation

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                                                                                                                                                                                          ANALYTICAL DEVELOPMENT & VALIDATION

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                                                                                                                                                                                          Cambrex focuses on efficiently developing robust and high- quality analytical methods that deliver reliable results. We have a vast range of capabilities in instrumentation and detectors including high-throughput column screening.

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                                                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                                                          Category: Analytical Method Development

                                                                                                                                                                                          Sub Category: Method Development and Validation
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                                                                                                                                                                                          AES Life Sciences

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                                                                                                                                                                                            METHOD DEVELOPMENT FOR BIOLOGICS USING CIF

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                                                                                                                                                                                            AES is a capillary electrophoresis service provider, It is dedicated for providing protein separation, quantification, and characterization. It also offers capillary electrophoresis method development for biologics.

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                                                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                                                            Category: Analytical Method Development

                                                                                                                                                                                            Sub Category: Capillary Electrophoresis
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                                                                                                                                                                                            Onyx Scientific

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                                                                                                                                                                                              ANALYTICAL DEVELOPMENT

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                                                                                                                                                                                              Onyx Scientific has a highly experienced team of analytical specialists to ensure all the analytical needs of their projects are met. All of Onyx’s methods are developed with cGMP quality & will be suitable for validation at the appropriate phase.

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                                                                                                                                                                                              Pharma Service: Analytical

                                                                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                                                                              AlbyPharma

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                                                                                                                                                                                                VALIDATION TESTING LABORATORY

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                                                                                                                                                                                                Raw material, intermediate testing, finished product testing, stability testing and validation testing laboratory.

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                                                                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                                                                Category: Analytical Method Development

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                                                                                                                                                                                                Appcure Labs

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                                                                                                                                                                                                  ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                  Appcure Labs delivers high-quality analytical development services including analytical methods development and validation, method transfer, cleaning methods development and validation, and stability studies as per ICH guidelines.

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                                                                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                                                                  Category: Analytical Method Development

                                                                                                                                                                                                  Sub Category: Method Development and Validation
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                                                                                                                                                                                                  Pfanstiehl

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                                                                                                                                                                                                  TEST METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                  Pfanstiehl synthesizes proprietary and commercial compounds in quantities ranging from grams to tons. Manufacturing and development take place within a 13-building campus located near Chicago, Illinois.

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                                                                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                                                                  Category: Analytical Method Development

                                                                                                                                                                                                  Sub Category: Method Development and Validation
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                                                                                                                                                                                                  Lamda Laboratories

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                                                                                                                                                                                                    METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                    Lamda’s analytical options are available on a stand-alone bases or as part of a full development package such as Analytical method development & Validation, Forced degradation studies, Photostability studies, Method transfer, API controls etc

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                                                                                                                                                                                                    Pharma Service: Analytical

                                                                                                                                                                                                    Category: Analytical Method Development

                                                                                                                                                                                                    Sub Category: Method Development and Validation
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                                                                                                                                                                                                    AES Life Sciences

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                                                                                                                                                                                                      METHOD DEVELOPMENT FOR RECOMBINANT PROTEINS

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                                                                                                                                                                                                      AES is a capillary electrophoresis service provider, It is dedicated for providing protein separation, quantification, and characterization. It also offers capillary electrophoresis method development for recombinant proteins.

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                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                      Category: Analytical Method Development

                                                                                                                                                                                                      Sub Category: Capillary Electrophoresis
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                                                                                                                                                                                                      Cyndea Pharma S.L

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                                                                                                                                                                                                        ANALYTICAL DEVELOPMENT

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                                                                                                                                                                                                        Cyndea Pharma focuses its efforts on the development and manufacturing of generic drugs with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with high activity products.

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                                                                                                                                                                                                        Pharma Service: Analytical

                                                                                                                                                                                                        Category: Analytical Method Development

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                                                                                                                                                                                                        Megsan Labs Private Limited

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                                                                                                                                                                                                        IMPURITY PROFILING

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                                                                                                                                                                                                        Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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                                                                                                                                                                                                        Pharma Service: Analytical

                                                                                                                                                                                                        Category: Analytical Method Development

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                                                                                                                                                                                                        Megsan Labs Private Limited

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                                                                                                                                                                                                        RESIDUAL GENOTOXIC IMPURITIES TESTING

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                                                                                                                                                                                                        Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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                                                                                                                                                                                                        Pharma Service: Analytical

                                                                                                                                                                                                        Category: Analytical Method Development

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                                                                                                                                                                                                        Olive Healthcare

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                                                                                                                                                                                                          ANALYTICAL METHOD DEVELOPMENT & EVALUATION

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                                                                                                                                                                                                          Olive healthcare is a fully integrated developer, manufacturer and marketer of broad range of soft gelatin formulations with a strong regulatory and infrastructure back end to support its r&d and growth strategy in global markets.

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                                                                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                                                                          Category: Analytical Method Development

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                                                                                                                                                                                                          UPM Pharmaceuticals

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                                                                                                                                                                                                          PURITY TESTING

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                                                                                                                                                                                                          UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

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                                                                                                                                                                                                          Pharma Service: Analytical

                                                                                                                                                                                                          Category: Analytical Method Development

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                                                                                                                                                                                                          AES Life Sciences

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                                                                                                                                                                                                            METHOD DEVELOPMENT FOR PEPTIDES

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                                                                                                                                                                                                            AES is a capillary electrophoresis service provider, It is dedicated for providing protein separation, quantification, and characterization. It also offers capillary electrophoresis method development for peptides.

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                                                                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                                                                            Category: Analytical Method Development

                                                                                                                                                                                                            Sub Category: Capillary Electrophoresis
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                                                                                                                                                                                                            PYRAMID Laboratories, Inc

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                                                                                                                                                                                                            METHOD DEVELOPMENT, VALIDATION AND SUPPORT TESTING

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                                                                                                                                                                                                            PYRAMID is highly specialized in the area of HPLC and GC method development. PYRAMID has an established reputation for developing methods for difficult and unusual compounds in complex products and matrices. All Validations are cGMP/ICH compliant.

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                                                                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                                                                            Category: Analytical Method Development

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                                                                                                                                                                                                            Rafarm S.A

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                                                                                                                                                                                                            DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS

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                                                                                                                                                                                                            Our researchers executes every phase of the development process with the utmost care, including identification of reliable suppliers of active ingredients, realization of laboratory and industrial-scale trial batches, development and validation of analytical methods and stability studies.

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                                                                                                                                                                                                            Pharma Service: Analytical

                                                                                                                                                                                                            Category: Analytical Method Development

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                                                                                                                                                                                                            AES Life Sciences

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                                                                                                                                                                                                              METHOD DEVELOPMENT FOR ADC

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                                                                                                                                                                                                              AES is a capillary electrophoresis service provider, It is dedicated for providing protein separation, quantification, and characterization. It also offers capillary electrophoresis method development for antibody drug conjugates.

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                                                                                                                                                                                                              Pharma Service: Analytical

                                                                                                                                                                                                              Category: Analytical Method Development

                                                                                                                                                                                                              Sub Category: Capillary Electrophoresis
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                                                                                                                                                                                                              Servier

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                                                                                                                                                                                                              ANALYTICAL DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                              Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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                                                                                                                                                                                                              Pharma Service: Analytical

                                                                                                                                                                                                              Category: Analytical Method Development

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                                                                                                                                                                                                              AES Life Sciences

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                                                                                                                                                                                                                METHOD DEVELOPMENT FOR MONOCLONAL ANTIBODIES

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                                                                                                                                                                                                                AES is a capillary electrophoresis service provider, It is dedicated for providing protein separation, quantification, and characterization. It also offers capillary electrophoresis method development for monoclonal antibodies.

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                                                                                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                                                                                Category: Analytical Method Development

                                                                                                                                                                                                                Sub Category: Capillary Electrophoresis
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                                                                                                                                                                                                                Novick Biosciences

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                                                                                                                                                                                                                  ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                                  Novick Biosciences is a CDMO which offers various services including Analytical method development & validation, Pre-formulation Development, Formulation development & Optimization, Scale Up & Technology transfer.

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                                                                                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                                                                                  Category: Analytical Method Development

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                                                                                                                                                                                                                  Servier

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                                                                                                                                                                                                                  IMPURITY TRACKING & CHARACTERIZATION

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                                                                                                                                                                                                                  Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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                                                                                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                                                                                  Category: Analytical Method Development

                                                                                                                                                                                                                  Sub Category: Impurity Isolation and Identification
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                                                                                                                                                                                                                  Avivia

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                                                                                                                                                                                                                    METHOD DEVELOPMENT AND VALIDATION

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                                                                                                                                                                                                                    We develop all methods that are needed in the different phases to support the chemical and pharmaceutical development, and when the time is there we transfer these methods to a qualified lab for the final quality testing.

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                                                                                                                                                                                                                    Pharma Service: Analytical

                                                                                                                                                                                                                    Category: Analytical Method Development

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                                                                                                                                                                                                                    Basic Pharma

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                                                                                                                                                                                                                      DESIGN & VALIDATE IN-HOUSE METHODS

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                                                                                                                                                                                                                      Basic Pharma Laboratory performs tests according to Ph. Eur. or USP methods; if no standard method is available, we are also able to design and validate in-house methods according to customer requirements.

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                                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                                                                                      PCI Pharma Services

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                                                                                                                                                                                                                      GMP AND ICH COMPLIANT METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                                      GMP and ICH compliant analytical equipment enabling our teams to perform simple ID testing and analytical method transfers, through method development and validation, to EU product release and ICH stability testing, ensuring data reliability and regulatory compliance.

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                                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                                                                                      Cambrex Corporation

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                                                                                                                                                                                                                      IMPURITY ISOLATION AND IDENTIFICATION

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                                                                                                                                                                                                                      At Cambrex we have a proven track record of identifying, isolating and characterizing impurities. Areas of expertise and capabilities include mass spectrometry (MS), preparative and semi-preparative chromatography, and NMR spectroscopy.

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                                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                                                                                      Globela Pharma

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                                                                                                                                                                                                                      ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                                      Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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                                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                                                                                      Pfanstiehl

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                                                                                                                                                                                                                      METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                                      Pfanstiehl produces proprietary and public domain compounds per cGMP guidelines. From a single kilogram for clinical trials to multi-ton commercial quantities, you can trust Pfanstiehl to help you move your product quickly to market.

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                                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                                      Category: Analytical Method Development

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                                                                                                                                                                                                                      DPT Laboratories, Ltd

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                                                                                                                                                                                                                      ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                                                                                                      Our comprehensive analytical method development and analytical validation services support both routine and esoteric drug development and commercial drug manufacturing projects.

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                                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                                      Category: Analytical Method Development

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