At Representative Projects Completed:
Representative Projects Completed:
- Technical Writing: Authored Process Development Report and Pharmaceutical Development Report; Authored 32P2 and 32P3 modules for ANDA (solid) and NDAs (solid and sterile); Provided summaries for Annual Stability Updates.
- Technial Review: Performed gap analysis for NDA and PPQ, and due diligence on developability of a sterile product for oncology; Reviewed existing development data for sterile solution, nanomilled suspension and lyophilized products and recommended development strategy.orki to develop appropriate drug product for phases of development.
- Collaboration with CMOs: Conducted CMO search for manufacturing of a sterile product with specialized sterilization requirement; supported transfer of a sterile product to CMO; provided CMC guidance and project management for product development and manufacture of registration bathces of drug+device combination product.