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Product release testing, also known as lot or batch release testing is an important step in the quality control process of drug substances and drug products. This testing verifies that a pharmaceutical or biopharmaceutical product meets a pre-determined set of specifications. These often include verification of the formulation’s identity, potency and purity, impurities, uniformity, identity, presentation attributes, and sterility. Products that require Release Testing to meet GMP compliance are: Raw drug substance materials & drug products that are to be used in clinical trials, Raw & in-process materials used in commercial production, Marketed products, Validation batches developed for utilization in an ICH stability study, etc. Contract Pharma Analytical service providers can develop, validate, and transfer even the most sophisticated analytical methods. They provide an accurate analysis of time-sensitive products that are under development to ensure that they can be quickly approved for release and distribution into the commercial marketplace. Good Manufacturing Practice (GMP) batch release testing is a necessary requirement to ensure high quality pharmaceuticals and biopharmaceuticals prior to release for sale, supply or export. Whilst a pharmaceutical company focuses on its core business activities, it also needs to select a partner who can assist with strong regulatory compliant batch release testing to a consistently high standard. The batch release testing teams utilise a wide range of analytical technologies to provide responsive release testing to ensure that healthcare products meet the product specification within the Marketing Authorisation (MA) or Clinical Trial Dossier (CTD). Batch release testing expertise includes chemical, physical and biological testing (including pharmacopeia analysis methods (BP, EP, JP and USP)). Our teams, based in our GMP compliant analytical laboratories, routinely work with clients around the globe to ensure that appropriate method transfer is performed.

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AMRI

Admix Pharma Laboratories, LLC

Aenova Group

Ash Stevens, Inc.

Basic Pharma

Boston Analytical

CARBOGEN AMCIS AG

Cebiphar

ChemCon GmbH

Chromcore Lifesciences

DPT Laboratories, Ltd

Delorbis Pharmaceuticals LTD

GVK Biosciences

Jubilant HollisterStier

KriSan Biotech

Megsan Labs Private Limited

Mithra CDMO

ORIT LABS LLC

PYRAMID Laboratories, Inc

Pace Analytical Services, LLC

Pharmathen SA

QUINTA-ANALYTICA s.r.o

Quantex Laboratories

RECRO GAINESVILLE

ScinoPharm Taiwan, Ltd

Stason Pharmaceuticals, Inc.

Tepnel Pharma Services

Vitas Analytical Services

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Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

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AMRI offers customized stability testing that includes developmental and packaging studies, stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothExperts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

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Recro provides various analytical testing services including raw material, in-process & finished product release testing, ICH stability testing, photo stability, physiochemical characterization, method development & validation, residual solvents by GC.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothA leading process R&D and API Manufacturing service provider to the Global Pharmaceutical Industry.

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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 Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothProviding Life Cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pharmathen’s offers cGMP Quality Control (QC) testing for excipients, intermediates, raw materials, APIs and GMP batch release testing for drug products supporting pharmaceutical development and manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

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Quinta-Analytica is a well-known and established company performing so called „import testing“. This is a testing of a batch manufactured outside EU which is planned for import and release within European market.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Tepnel is a QC testing laboratory that provides batch release & lot release testing. They have a wealth of experience across a wide range of small molecule, inhalation drug products & biopharmaceutical product types in accordance with the requirements

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

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AMRI provides the resources and flexibility to develop and improve analytical methods tailored to your specific needs.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothProviding Life Cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pharmathen’s offers cGMP Quality Control (QC) testing for excipients, intermediates, raw materials, APIs and GMP batch release testing for drug products supporting pharmaceutical development and manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Quantex Laboratories supports your product Quality Control and Release Testing needs for Active Ingredients intermediates, excipients and finished products. We have experience testing for many types of formulations.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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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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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Vitas has a manufacturing authorization for medicinal products (Quality Control testing). Vitas has internal procedures for release of Quality Control data on samples covering the range from clinical trial to medicinal products offered for sale.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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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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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Our mission is to support you in the compliance of your products by providing quality control analysis services as part of validation and release of production batches.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot 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 Testing Services

Sub Category: Batch Release and Stability Lot Testing