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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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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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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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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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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CARBOGEN AMCIS' forced degradation studies and stress tests encompass stress testing under acid or alkaline conditions, oxidative stress testing, and photostability studies. Based on the innovator’s specific needs, we can develop and tailor stability studies as well as forced degradation

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Tepnel Pharma Services is an approved and accredited QC testing laboratory with a long history of batch release and lot release testing. We provide a wealth of experience across a wide range of small molecule, inhaled products and biopharmaceutical product types in accordance with the requirements

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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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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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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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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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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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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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DELORBIS also offer services such as EU batch testing and release of pharmaceutical 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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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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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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Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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KriSan Biotech helps to establish specification for raw materials, intermediates, and APIs as well as release testing.

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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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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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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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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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Aenova offers testing and release of active pharmaceutical ingredients and excipients according to monograph or customer specifications

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PYRAMID has over 4,000-sq. ft. of dedicated laboratory area with state of the art equipments. PYRAMID is a FDA registered Facility. All analyses are performed according to the applicable GLP and cGMP guidelines and regulations as documented in the Code of Federal Regulations (CFR) Title 21.