Chemistry, Manufacturing and Controls (CMC)

Intrinsik’s scientific experts specialize in the review of chemistry, manufacturing and controls (CMC) data and preparation of regulatory documents supporting all phases of development. Our range of services help sponsors navigate the CMC regulatory landscape and produce high-quality submissions.

Services:

CMC support is offered for small molecules and biologics (recombinant proteins, monoclonal antibodies, vaccines, gene therapies, blood products, etc.)
Authoring of CTD Modules 2.3 and 3 supporting US and Canadian submissions (IND/CTA, DMF, NDA/NDS and post-approval)
Risk-based gap analyses to meet regional submission requirements based on current agency guidance and emerging trends
Post-approval change assessments for regulatory filing type and content
Global regulatory CMC strategies including lifecycle management

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 - CMC

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.