Regulatory Affairs and Compliance for Biopharmaceutical Services

Charles River’s Biopharmaceutical Services (BPS) functions as the central point of service for biological product testing. Essential to the provision of these services is a comprehensive understanding of the changing regulatory environment and systems that assure compliance with worldwide regulatory bodies. Our quality assurance staff understands these requirements, and our facilities are designed to provide a testing environment that will satisfy quality and compliance needs.

To address these needs, BPS provides:

• Guideline review from regulatory agencies worldwide to ensure that recommendations made for safety testing from raw materials screening to final drug product are consistent with current worldwide approaches
• Program design based on recommendations from the USFDA, the Committee for Proprietary Medicinal Products, the Japanese Ministry of Health and Welfare, and the ICH
• Assays which comply with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP), 9 CFR, and 21 CFR specific requirements
• A Drug Master File (DMF) filed with the USFDA to support regulatory submissions
• A facility that has been audited by both the FDA and the EMEA regarding services provided in support of products at all phases of clinical trials, including licensed products for both the US and Europe  
• GLP (21 CFR Part 58) and cGMP-compliant (21 CFR Part 210,211) testing that is consistent with global regulatory requirements for materials used for therapeutic and in vivo diagnostic use
• Validated biological and analytical methods in compliance with cGMP and ICH documents
• Product-specific biological and analytical assays used in support of marketed products

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