We have extensive knowledge of the regulation of biotechnology derived medicinal products and constantly monitor regulatory documentation to provide clients with the most up to date testing and manufacturing plans. The most appropriate use of current guidance is essential in ensuring the most timely, cost effective and successful licensing of the therapeutic product.

The specific testing requirements for different stages of development, i.e., preclinical, clinical, and licensure, may vary worldwide. BioReliance is experienced in working with clients to satisfy questions raised by the regulatory agencies worldwide. Our services assist clients in allowing their testing programs to meet current worldwide regulatory expectations. This added value service can prevent regulatory holds that delay marketing of pharmaceutical products. In some cases, we contact the regulatory agencies with or on behalf of our clients. We also work internally with Quality Assurance and Laboratory personnel to ensure that BioReliance complies with the latest regulations.

BioReliance provides a range of Regulatory & Technical Services activities including advice and consultancy in support of dossier preparation and submissions. Specific reports can be prepared depending on our client’s unique requirements. These can be provided as stand-alone documents or as part of the entire submission.

Therefore, BioReliance’s Regulatory & Technical Services group provides:

• Regulatory information services
• Ensuring up to date advice
• Advice on regulatory strategies
• Data review and evaluations
• Expert report writing
• Preparation of documentation
• Response to authorities
• Technical support