CMC CTD Support
- Registration Starting Material Strategy
- Impurity management – fate and linkage
- Potential Genotoxic Impurity Management
- API manufacture and analytical information in formats appropriate for inclusion in regulatory filings (CTD Section 3.2.S.1 through 3.2.S.7)
- Service Overview
- Discovery Chemistry
- Biology & Pharmacology
- DMPK / Exploratory Toxicology
- Biologics Discovery
- Biologics CMC
- Small Molecule CMC