Chemistry, Manufacturing and Controls (CMC)

Intrinsik’s scientific experts specialize in the preparation and review of chemistry, manufacturing and controls (CMC) data during all phases of development.

Services:

CMC support for small molecules and biologics
Authoring of CTD Modules 2.3 and 3
Drug Master Files
Global regulatory CMC strategies including lifecycle management
Gap analysis and technical assessment to meet regional requirements

Chemistry, Manufacturing and Controls (CMC) Team

Katharine Manson

B.Sc. (Hons.)

Vice President, Regulatory Affairs

Kathryn Farmer

B.Sc. (Hons.), RAC

Associate Director, Regulatory Affairs

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.