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Batch Reslease & Stability Lot Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

Cebiphar' services, among others, is the analysis of your samples during pre and post MA stability studies (all ICH-VICH conditions, stress testing studies, photostability studies, transport studies) and batch release testing of your FDFs.

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Batch Release & Stability Lot Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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

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Customized Stability & Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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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ICH-Compliant Stability Studies

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

We provide a full custom manufacturing service to customers looking for a flexible and qualified partner able to produce parenterals in accordance with their specifications. We work in strict accordance to the EU GMP, Good Distribution Practices (GDP), and documented Standard Operating Procedures

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Quality Control & Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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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Lot Release & Stability Assessment

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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

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Quality Control Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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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Commercial Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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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Release Testing of Incoming Materials / Finished Products

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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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Quality Control & Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development and validation, as well as stability testing. All analytical instruments and data are managed through the company's Laboratory Information Management System

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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