Chemistry, Manufacturing & Controls
- CMC (Quality) Data Review and Gap Analysis
- Process control & characterization
- Analytical and bioanalytical methods validation
- Extractables and Leachables
- Photostability studies
- Technology transfers
- Comparability studies
- Investigational Medicinal Product Dossier (IMPD) quality documentation writing
- New Drug Application (NDA) writing of Module 2 & 3
- Clinical trial supply logistics
- Serialization setup