GMP - Development for Small Molecules in Pharmaceutics, Generics, Diagnostics and Research Chemicals, applicable for pre-clinic studies, all clinic phases up to commercial material

on this basis ChemCon offers:

  • Process transfer from R&D to CGMP (Material for pre-clinic tests, all clinic phases up to commercial material)

  • Scale up from Milligram to Kilogram

  • Process validation

  • Complete Sets of GMP-Documentation (Type II Drug Master Files, CGMP Master Batch Records, CGMP Master Cleaning Records) in full compliance with all FDA guidelines.