Consulting Services
Our scientists have extensive knowledge of the manufacturing, safety and quality 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.
BioReliance provides a range of biosafety, manufacturing and regulatory consulting services including support of dossier preparation and submissions.
For Biologics Biosafety, Manufacturing and Regulatory Support, please contact info@bioreliance.com
For Preclinical Toxicology and Regulatory Support, please contact tox@bioreliance.com
