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    Looking for method development & validation? Find service providers offering process development & optimization, method transfer on PharmaCompass.

    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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    ANALYTICAL DEVELOPMENT SERVICES

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

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    Analytical Development Services

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    Bachem AG

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    Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

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    Analytical Method Development & Validation

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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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    Pharma Service: Analytical

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    Quotient Sciences Analytical Method Development & Validation

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    Cayman Chemical Company Inc

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    CHEMICAL TESTING METHODS

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification

    Cayman

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    ZACH System SA

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    ANALYTICAL DEVELOPMENT

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation

    Zach Analytical Development

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    Century Pharmaceuticals

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    Virtual BoothCentury has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
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    ANALYTICAL METHOD DEVELOPMENT

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

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    Category: Analytical Method Development

    Sub Category: Overview

    Century Pharmaceuticals Analytical Method Development

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    Fermion Oy

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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation

    Analytical Method Development & Validation

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    Mission | CDMO

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    Virtual BoothMission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.
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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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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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    Pharma Service: Analytical

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    Analytical Method Development & Validation

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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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    Analytical Method Development & Validation

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    M2i Group

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    Virtual BoothM2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.
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    ANALYTICAL METHOD DEVELOPMENT

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

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    M2i Group Analytical Method Development

    CPhI Japan

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    Mikart

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    Virtual BoothAs a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
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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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    Pharma Service: Analytical

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    Analytical Method Development & Validation

    CPhI North America

    Booth #420

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    Bora Pharmaceuticals

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    ANALYTICAL METHOD DEVELOPMENT

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

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    Analytical Method Development

    BIO Int. Convention

    Booth #5651

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    Sharp

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    Virtual BoothSharp is a global leader in pharmaceutical packaging and clinical trial supply services.
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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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    Category: Analytical Method Development

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    Clinical Analytical & Research Services

    CPhI North America

    Booth #1106

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    Seqens

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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
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    ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation

    Analytical Method Development and Validation

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    Prague Scientific

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    Virtual BoothPrague Scientific offers services across different areas in development, regulatory & pharmacovigilance.
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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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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation

    Prague Scientific Analytical Development

    CPhI Japan

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    FumoPrep

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    Virtual BoothFumoPrep is a GLP-certified CRO with unique solutions.
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    ANALYTICAL METHOD DEVELOPMENT

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Overview

    Analytical Method Development

    CPhI Japan

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    Renejix

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      CHIRAL HPLC & SFC METHOD DEVELOPMENT

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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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      Pharma Service: Analytical

      Category: Analytical Method Development

      Sub Category: Chiral HPLC & SFC Method Development

      Chiral HPLC & SFC Method Development

      CPhI Japan

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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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      Category: Analytical Method Development

      Sub Category: Method Development and Validation

      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

      Category: Analytical Method Development

      Sub Category: Method Development and Validation

      Analytical Method Development & Validation

      CPhI Japan

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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

        Category: Analytical Method Development

        Sub Category: Impurity Isolation and Identification

        Impurity Isolation

        CPhI Japan

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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

          Sub Category: Method Development and Validation

          Analytical Method Development & Validation

          CPhI Japan

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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

            Sub Category: Overview

            Analytical Method Development

            CPhI Japan

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            Renejix

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              Virtual BoothRenejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
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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

              Sub Category: Preparative Resolution Processes

              Preparative Resolution Processes

              CPhI Japan

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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

                CPhI Japan

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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

                Category: Analytical Method Development

                Sub Category: Method Development and Validation
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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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                  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

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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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                  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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                  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

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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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                    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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                    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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                    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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                      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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                      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

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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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                      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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                        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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                          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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                          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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                          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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                          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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                          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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                            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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                              Category: Analytical Method Development

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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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                                Category: Analytical Method Development

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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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                                  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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                                  Category: Analytical Method Development

                                  Sub Category: Chiral HPLC & SFC 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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                                    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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                                        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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                                          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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                                            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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                                              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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                                                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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                                                    Pharma Service: Analytical

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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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                                                    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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                                                      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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                                                      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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                                                          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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                                                            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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                                                              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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                                                                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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                                                                  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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                                                                  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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                                                                      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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                                                                      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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                                                                        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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                                                                          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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                                                                          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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                                                                          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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                                                                              Category: Analytical Method Development

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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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                                                                                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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                                                                                  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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                                                                                      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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                                                                                          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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                                                                                          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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                                                                                            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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                                                                                            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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                                                                                            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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                                                                                            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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                                                                                            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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                                                                                              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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                                                                                              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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                                                                                                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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                                                                                                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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                                                                                                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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                                                                                                  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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                                                                                                  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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                                                                                                    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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                                                                                                      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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                                                                                                      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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                                                                                                              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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                                                                                                                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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                                                                                                                  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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                                                                                                                    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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                                                                                                                    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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                                                                                                                      Pharma Service: Analytical

                                                                                                                      Category: Analytical Method Development

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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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                                                                                                                        Pharma Service: Analytical

                                                                                                                        Category: Analytical Method Development

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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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                                                                                                                        Pharma Service: Analytical

                                                                                                                        Category: Analytical Method Development

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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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                                                                                                                          Pharma Service: Analytical

                                                                                                                          Category: Analytical Method Development

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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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                                                                                                                          Pharma Service: Analytical

                                                                                                                          Category: Analytical Method Development

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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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                                                                                                                            Pharma Service: Analytical

                                                                                                                            Category: Analytical Method Development

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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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                                                                                                                              Pharma Service: Analytical

                                                                                                                              Category: Analytical Method Development

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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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                                                                                                                                Category: Analytical Method Development

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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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                                                                                                                                  Pharma Service: Analytical

                                                                                                                                  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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                                                                                                                                      Pharma Service: Analytical

                                                                                                                                      Category: Analytical Method Development

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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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                                                                                                                                        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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                                                                                                                                          Pharma Service: Analytical

                                                                                                                                          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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                                                                                                                                            Pharma Service: Analytical

                                                                                                                                            Category: Analytical Method Development

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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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                                                                                                                                              Pharma Service: Analytical

                                                                                                                                              Category: Analytical Method Development

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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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                                                                                                                                              Pharma Service: Analytical

                                                                                                                                              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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                                                                                                                                              Pharma Service: Analytical

                                                                                                                                              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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                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                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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                                                                                                                                                Pharma Service: Analytical

                                                                                                                                                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

                                                                                                                                                  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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                                                                                                                                                    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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                                                                                                                                                      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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                                                                                                                                                        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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                                                                                                                                                          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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                                                                                                                                                            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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                                                                                                                                                            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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                                                                                                                                                            Category: Analytical Method Development

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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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                                                                                                                                                            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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                                                                                                                                                              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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                                                                                                                                                              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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                                                                                                                                                                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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                                                                                                                                                                  Category: Analytical Method Development

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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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                                                                                                                                                                    Category: Analytical Method Development

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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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                                                                                                                                                                    Category: Analytical Method Development

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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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                                                                                                                                                                      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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                                                                                                                                                                        Category: Analytical Method Development

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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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                                                                                                                                                                          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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                                                                                                                                                                          Category: Analytical Method Development

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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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                                                                                                                                                                            Category: Analytical Method Development

                                                                                                                                                                            Sub Category: Chiral HPLC & SFC Method Development
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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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                                                                                                                                                                            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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                                                                                                                                                                              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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                                                                                                                                                                              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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                                                                                                                                                                                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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                                                                                                                                                                                  Pharma Service: Analytical

                                                                                                                                                                                  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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                                                                                                                                                                                    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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                                                                                                                                                                                    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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                                                                                                                                                                                      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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                                                                                                                                                                                        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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                                                                                                                                                                                        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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                                                                                                                                                                                        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

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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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                                                                                                                                                                                          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

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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

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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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                                                                                                                                                                                                  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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                                                                                                                                                                                                    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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                                                                                                                                                                                                      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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                                                                                                                                                                                                        Category: Analytical Method Development

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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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                                                                                                                                                                                                        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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                                                                                                                                                                                                          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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                                                                                                                                                                                                            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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                                                                                                                                                                                                            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

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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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                                                                                                                                                                                                              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 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

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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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                                                                                                                                                                                                                  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

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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

                                                                                                                                                                                                                      Sub Category: Method Development and Validation
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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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                                                                                                                                                                                                                      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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                                                                                                                                                                                                                      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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                                                                                                                                                                                                                      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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                                                                                                                                                                                                                      Servier

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                                                                                                                                                                                                                      IDENTIFICATION OF PHARMACEUTICAL IMPURITIES

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                                                                                                                                                                                                                      Servier brings 60 years of experience in process development, intermediates, APIs and high-potency APIs. Our full cGMP?/?FDA-approved chemistry network includes R&D, production and supply chain expertise with full regulatory support.

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                                                                                                                                                                                                                      Pharma Service: Analytical

                                                                                                                                                                                                                      Category: Analytical Method Development

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