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
  • Product Development Reports
  • Drug Master Files
  • Global regulatory CMC strategies including lifecycle management
  • Gap analysis and technical assessment to meet regional requirements

 

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.

Contact Us