Your Regulatory CMC Roadmap: Clinical Development Considerations For Small Molecules And Recombinant Proteins

The distinctions between Chemistry, Manufacturing, and Controls (CMC) and Regulatory CMC expertise are significant, and the absence of internal Regulatory CMC expertise in biotechnology and pharmaceutical companies can lead to overlooked considerations throughout the product development lifecycle. Companies often manage assets across various modalities, such as small molecules and recombinant proteins, each requiring a deep understanding of specific requirements and considerations.

Critical questions arise, including: What are the key Regulatory CMC priorities and focus areas for each phase of clinical development? How do strategies differ between small molecules and recombinant proteins? What major pitfalls should be avoided, and how can they be prevented? What are the best practices for determining the level of detail needed in health authority filings? And how does Regulatory CMC strategy shape and influence overall CMC planning?

These questions underscore the importance of having specialized Regulatory CMC expertise to navigate the complex landscape of drug development effectively. Watch the webinar below for answers to these questions and learn how to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.