The CR Medicon team has extensive experience with new drug regulatory policies in both China and the United States. We have already served multiple clients who have conducted synchronous clinical development in US and China.
Integrated Services & Advantages
US-China coordinated dual registration and clinical development under a single development strategy
IND (phases I, II, III, IV) application, NDA (505(b)(1), (505(b)(2)) and ANDA/BLA filing, DMF/CEP registration
US-China dual registration and development strategy consulting, as well as providing reviews and defect analysis of the registration materials
Support communications and meetings with FDA and NMPA
Conduct high-quality and complex early clinical drug development for non-critical diseases in our clinical pharmacology center in Baltimore, USA