Organic process R&DCustom synthesis and scale upSupply of pre-clinical to clinical trial APIsTransfer of technology & cGMP support to domestic and overseas factoriesCMC regulatory files for use in IND/IMPD/ANDAAPI solid state studiesImpurity preparation and controlPreparation and structural identification for reference standard/working standardAnalytical R&DAnalytical method validationForced degradation studies and stability t...
Organic process R&DCustom synthesis and scale upSupply of pre-clinical to clinical trial APIsTransfer of technology & cGMP support to domestic and overseas factoriesCMC regulatory files for use in IND/IMPD/ANDAAPI solid state studiesImpurity preparation and controlPreparation and structural identification for reference standard/working standardAnalytical R&DAnalytical method validationForced degradation studies and stability testsIdentification and structural elucidation for impurities, reference standards and working standardsPre-formulation studiesFormulation design and developmentProcess scale up and optimizationDissolution studiesRegulatory file for use in IND/IMPD/ANDA/SFDA registrations
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