Project transfer from R&D into cGMP is the core competency of ChemCon. We perform scale-up and chemical process development to bring your project into cGMP production. With our stringent good manufacturing practices and regulatory compliance, we have prepared numerous CMC sections for clients' IND, NDA and ANDA filings. Our dedicated project manager works in close communication with our analytical department and QA to ensure a smooth transfer into cGMP.

ChemCon manufactures cGMP material for all clinical phases and for commercial purposes.
Our regulatory affairs staff possesses extensive experience bringing projects into the commercial phase. We are currently manufacturing for multiple active DMFs.

ChemCon’s strategy is to use dedicated equipment for each project once the production is under cGMP. This is the most effective way to ensure there is no cross contamination. Moreover, rigid waste management is in place.