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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.
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