lot & final drug product release
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All products entering local or global pharmaceutical markets require Good Manufacturing Practice (GMP) testing to ensure that they are released in accordance with regional and global regulatory authority guidelines. Release testing packages comprise a range of studies previously validated to demonstrate compliance of a product. The Biopharmaceutical Services (BPS) groups at Charles River provides product release testing services for client-derived and BPS-derived intermediate and final drug products. The BPS group provides release services for the European Union (EU), US, and other regulatory-distinct markets, and can act as a single site for global release testing for clients.
We provide a full range of support for our clients, from addressing biosafety concerns and analyzing potency using suitable bioassays to determine purity and other biochemical characteristics. Our commitment to providing rapid turnaround times for all testing helps minimize the period between production and release.
Key Features
- EU Release
- Technology Transfer
- Biochemical Analysis
- Potency
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Lot release, lot release testing, release testing, GMP, product release testing, biosafety testing, biochemical analysis, potency analysis
Lot Release Testing | Charles River
Charles River Biopharmaceutical Services provides lot and final drug product release testing services for the European Union (EU), US, and other regulatory-distinct markets, and can act as a single site for global release testing for clients.