Regulatory Affairs for Preclinical Services

Charles River’s reputation for expert advice and regulatory services is well established providing you with first class advice on the development and registration of your products.  We adopt a flexible approach, working with you on both short-term and long-term projects, each undertaken with equal enthusiasm.

Our regulatory staff plays a key role in all project teams and provides support during preclinical and clinical development, product license applications, and regulatory approvals.

Services include

• Data review, gap analysis, and strategic advice
• Development and registration strategies
• Clinical trial applications and clinical trial support services
• Product registration and marketing applications
• Product license variations and product defense

Quality Assurance

At Charles River, we have expertise in both the development of protocols and the review of studies for regulatory submissions. We consistently meet or exceed regulatory standards for quality and compliance. Our commitment to regulatory compliance is evidenced both by our internal quality assurance programs and by our scientists, many of whom serve on FDA, EPA, OECD, and WHO advisory panels. In addition, numerous Charles River Quality Assurance Unit (QAU) staff are opinion leaders in their field and committee members of their professional bodies, such as SQA and BARQA.

Charles River’s QAU designs and undertakes all audit programs to meet and comply with the appropriate international GLP, GMP and GCPv guidelines. We can also design customized audit programs that incorporate client specific QA requirements. The focus of the QAU program includes:

• Study protocol review and schedule preparation of planned critical phase inspections
• Study-based critical activity inspections
• Process-based inspections
• Facility inspection planning and conduct
• Study specific report audits
• Suppliers and subcontractors audits
• Validation study audits
• Computer system audits to comply with electronic record guidelines

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