Our Regulatory Compliance experts have experience in the field, as the client, and as ex-FDA investigators. These SMEs provide sound guidance based on best practices and all applicable regulations/ guidance.
Planning
Expertise in Strategic and Tactical Planning and Execution of life-cycle CMC development and world-wide regulatory agency interactions
Knowledge and experience in Protein Biology, Biotechnology, Biologics Commercialization, and Regulatory Affairs
Change Management
Experience in establishing strategy for moving through early to late phase production/commercialization while managing phase-appropriate change and scalability