Manufacturing
- Drug substance/Drug Product
- Selection of CDMO/CMO
- Develop Quality Assurance/Technical Agreement
- Vendor Oversight
- Support API synthesis evaluation
- Develop specifications, process controls
- Testing Methods
- Phase appropriate validation
- Stability studies
- Establish retest date
- QC support
- Handling excursions
- Analyze trends/patterns
- Supply Chain
Drug Delivery Systems
- Tablets
- Capsules
- Liquid/liquid gel
- Semi-solids
- Injectables/sterile