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.