Synthesis, Route and Process Development
- Route Scouting, route development, scaleup and safety
- Crystallization, solubility and polymorphism
- Phase appropriate batch delivery - purity, ICH guidance
Outsourcing
- RFPs, Vendor Selection, Technical Transfer
- Batch records, batch execution
- API release
- cGMP
Project Planning
- Regulatory Document Submissions
- Batch Planning
- Coordination with QA, Analytical, Formulation, Finance and other stake holders
Laboratory Fabrication and Set Up
- Reactor and Equipment Selection
- Infrastructure Lay out and supply of services
- Setup and commissioning