CMC

Services include contract research and development and analysis for the purpose and regulatory dossier development as well as the corresponding registration   applications.

Production process study

Route investigation and determination Laboratory & pilot level

Key starting materials and intermediates contol

Process transfer

Characterization

API structure identification

Impurity synthesis, isolation, structure identification (NMR/LC-MS/MS/IR/UV)

Quality research

Analysis method development, validation,transfer,re-validation

Specifications development and establishment

Working standard qualification

Stability studies

Influencing factors stability studies,accelerated stability

Studies and long-terms stability studies

Registration Applications

Local drug registration applications

Draft DMF in CTD format with CMC dossier submisssions

Provide consultation on the Chinese registration regulations and assistance of on-site inspections