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.
- 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