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Your Regulatory CMC Roadmap: Clinical Development Considerations for Small Molecules and Recombinant Proteins

Thursday, Aug 1, 2024

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Join Halloran’s Regulatory CMC team for a live webinar – They will walk you through critical questions and provide examples and scenarios, highlighting your successful Regulatory CMC roadmap across the clinical development lifecycle.

The differences in Chemistry, Manufacturing, and Controls (CMC) and Regulatory CMC expertise are vast. When biotechnology and pharmaceutical companies do not have internal Regulatory CMC expertise, key considerations can be missed throughout their product’s development lifecycle. Often, companies hold assets across a broad range of modalities, including both small molecules and recombinant proteins, which requires a nuanced understanding of the requirements and considerations for each product type.

Perhaps you’ve been asking the following questions:

  • What are Regulatory CMC critical priorities and focus areas for each phase of clinical development?
  • What are the key differences in Regulatory CMC strategy for small molecules and recombinant proteins?
  • What are the big pitfalls to avoid? How do I avoid them?
  • What are the key strategies in knowing when and how much detail to include in my health authority filings?
  • How does Regulatory CMC strategy impact and influence CMC strategy and planning?


  • Shawn Roach, Senior Consultant, Halloran, Moderator
  • Rania Jalal, Senior Consultant, Halloran
  • Ros Hafen, Senior Consultant, Halloran


12:00 PM Eastern Daylight Time