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    Analytical Method Development and Validation Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Appropriate analytes of interest for testing are to be dertermined. Drawing from resources available in literature, or performing extractables profiles in chemistry laboratory, specific analytes of interest for a drug product are determined. Methods are dev

    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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    Famar

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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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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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    Pharma Service: Analytical

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    Analytical Method Development & Validation

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    Skyepharma

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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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    Analytical Development Services

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    Bachem AG

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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

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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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    Quotient Sciences Analytical Method Development & Validation

    CPhI North America

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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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    ZACH System SA

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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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    Zach Analytical Development

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    Fermion Oy

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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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    Analytical Method Development & Validation

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    Mission | CDMO

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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

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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 Group

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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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    M2i Group Analytical Method Development

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    Mikart

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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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    Sharp

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    CLINICAL ANALYTICAL & RESEARCH SERVICES

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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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    Clinical Analytical & Research Services

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    Seqens

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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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    FumoPrep

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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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    Analytical Method Development & Validation

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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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      Analytical Method Development & Validation

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      Acceleration Laboratory Services

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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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      Menadiona

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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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      Societal CDMO

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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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      Angelini Pharma

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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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      KriSan Biotech

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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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        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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          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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          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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            Curia

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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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            Solara Active Pharma Sciences

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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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            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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              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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              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

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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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                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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                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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                  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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                    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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                    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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                    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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                    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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                      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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                        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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                          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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                            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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                              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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                                PSR Pharma Science and Research

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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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                                    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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                                    Prague Scientific

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                                    ANALYTICAL DEVELOPMENT

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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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                                    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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                                    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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                                    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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                                      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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                                        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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                                          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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                                            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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                                            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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                                            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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                                            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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                                            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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                                              ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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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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                                              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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                                              Unither Pharmaceuticals

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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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                                              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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                                              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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                                                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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                                                  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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                                                    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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                                                      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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                                                        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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                                                            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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                                                                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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                                                                  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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                                                                    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 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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                                                                        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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                                                                        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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                                                                          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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                                                                            Catalent Pharma Solutions

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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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                                                                            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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                                                                            Provepharm Life Solutions

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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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                                                                            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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                                                                              Tapemark Company

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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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                                                                              Curtis Health Caps

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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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                                                                                Softigel Procaps

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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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                                                                                Solvias

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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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                                                                                DPT Laboratories, Ltd

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

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                                                                                Symbiosis Pharmaceutical Services

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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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                                                                                  Doctor's Analytical Laboratories

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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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                                                                                    Megsan Labs Private Limited

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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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                                                                                    Osmopharm

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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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                                                                                      Evotec

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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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                                                                                      Eurofins BioPharma Services

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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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                                                                                        Arcinova

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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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                                                                                          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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                                                                                          Labiana Life Sciences S.A

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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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                                                                                          Zelmic

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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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                                                                                            Chromcore Lifesciences

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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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                                                                                              Ortiv-Q3 Research

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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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                                                                                                Bluepharma

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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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                                                                                                Cambrex Corporation

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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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                                                                                                Lonza Capsugel

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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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                                                                                                SGS Life Sciences

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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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                                                                                                Almelo

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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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                                                                                                  Appcure Labs

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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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                                                                                                    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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                                                                                                      Onyx Scientific

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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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                                                                                                        Lamda Laboratories

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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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                                                                                                          Cyndea Pharma S.L

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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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                                                                                                            Pfanstiehl

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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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                                                                                                            Olive Healthcare

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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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                                                                                                              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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                                                                                                              Servier

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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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                                                                                                              Rafarm S.A

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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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                                                                                                              Avivia

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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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                                                                                                                Novick Biosciences

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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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                                                                                                                  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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                                                                                                                    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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                                                                                                                    Legacy Pharmaceuticals Switzerland

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                                                                                                                      PROCESS VALIDATION & VALIDATION OF ANALYTICAL METHODS

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                                                                                                                      Legacy Pharmaceutical supports you with process development, process validation & validation of analytical methods, commercial production, & sales of your products. Perfect planning and sustainable documentation result in successful product transfer.

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                                                                                                                      Stason Pharmaceuticals, Inc.

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                                                                                                                      METHOD DEVELOPMENT & VALIDATION

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                                                                                                                      Analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. We also have a DEA analytical permit for CII-CIV products.

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                                                                                                                      Avaca Pharma

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                                                                                                                        ANALYTICAL DEVELOPMENT & VALIDATION

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                                                                                                                        AvacaPharma's scientific team has an up to date understanding of product development aspects. Analytical scientists focuses on method development, validation, instrumentation, technology transfer and stability studies.

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                                                                                                                        Diverchim S.A.

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                                                                                                                        ANALYTICAL VALIDATION

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                                                                                                                        In accordance with the ICH Q7 and the cGMP guidelines, DIVERCHIM validates the analytical methods developed by its teams to ensure registration and marketing authorizations by Health Agencies.

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                                                                                                                        Biolink LifeSciences

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                                                                                                                          ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                          Biolink Life Sciences offers a full range of services including analytical method development & validation, custom synthesis, process development, stability studies, reference standard synthesis, pre-formulation & formulation development services.

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                                                                                                                          M2M Pharmaceuticals Ltd

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                                                                                                                            METHOD DEVELOPMENT AND VALIDATION

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                                                                                                                            M2M Pharmaceuticals Ltd, a Contract Research Organization (CRO) supports early stage product development for pharmaceutical, food and biotech companies with various services in Method Development and Validation, Physico-Chemical Analysis, Formulation and Quality/Regulatory support.

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                                                                                                                            Pace Analytical Services, LLC

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                                                                                                                              METHOD DEVELOPMENT & VALIDATION

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                                                                                                                              Pace Analytical Life Sciences offers microbiology laboratory services for the qualitative and quantitative assessment of products, packaging and the manufacturing environment.

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                                                                                                                              Farmhispania

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                                                                                                                              ANALYTICAL METHOD VALIDATION / VERIFICATION

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                                                                                                                              Farmhispania Group offers custom process development and custom manufacturing services for API’s, advanced intermediates and building blocks for the pharmaceutical, biopharmaceutical and related industries.

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                                                                                                                              Pharma Service: Analytical

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                                                                                                                              GALENIX INNOVATIONS

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                                                                                                                                ANALYTICAL DEVELOPMENT AND VALIDATION

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                                                                                                                                With more than 15 years of know how, experience, and a very large state-of-the art analytical platform, Galenix performs analytical development and validation works in very short timeframes.

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                                                                                                                                Pharma Service: Analytical

                                                                                                                                Category: Analytical Method Development

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                                                                                                                                Lubrizol Life Science Health

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                                                                                                                                METHOD DEVELOPMENT AND VALIDATION

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                                                                                                                                The work in Analytic Services ranges from early method development through and onto validation and clinical and commercial support. With decades of experience, our staff will help you design and successfully execute a phase-appropriate analytical strategy

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                                                                                                                                Avaca Pharma

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                                                                                                                                  METHOD DEVELOPMENT, VALIDATION & TRANSFER

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                                                                                                                                  AvacaPharma's scientific team has an up to date understanding of product development aspects. Analytical scientists focuses on method development, validation, instrumentation, technology transfer and stability studies.

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                                                                                                                                  Megsan Labs Private Limited

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                                                                                                                                  METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                  Analytical method development and validation services are performed as per ICH Qz, |JSP , method verifications as per <1226>, and/or customer requirements.

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                                                                                                                                  Globela Pharma

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                                                                                                                                  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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                                                                                                                                  Siegfried AG

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                                                                                                                                  500 METHOD VALIDATIONS IN ACCORDANCE WITH ICH GUIDELINE...

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                                                                                                                                  Our analytical departments support the whole product lifecycle of drug substances and drug products with scientific competence and an extensive instrument pool. Validation, verification and Transfer of analytical methods.

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                                                                                                                                  Ardena

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                                                                                                                                    ANALYTICAL METHOD DEVELOPMENT

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                                                                                                                                    Ardena’s state-of-the-art, GMP qualified, equipment and facilities offer analytical method development services to support the development of drug substances and complex bulk drug products like nano-formulations.

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                                                                                                                                    Aragen Life Sciences

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                                                                                                                                    METHOD DEVELOPMENT, VALIDATE & TRANSFER

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                                                                                                                                    GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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                                                                                                                                    Aragen Life Sciences

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                                                                                                                                    METHOD DEV., QUALIFICATION, VALIDATION & TRANSFER

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                                                                                                                                    GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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                                                                                                                                    Cebiphar

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                                                                                                                                    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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                                                                                                                                    Preparation of monographs, Development, validation and transfer of physicochemical methods, Stability indicating assay methods for active ingredients, degradation, products and preservatives, Discriminating dissolution tests, Determination of impurities.

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                                                                                                                                    Pharma Service: Analytical

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