R&D, Supply and Registration Support for New Drugs 
 

·Performed process R&D and scale up on new molecule entity API for the US customer since 2005. 

·The candidate had poor bioavailability. Based on a suggestion to improve bioavailability, made the first sample
　of a novel prodrug. Bioavailability improvement was proven. 

·Our work included cGMP preparation for API. Identification, preparation and profile for tens of impurities.
　Analytical method development and validation. API stability study and solid state studies.
　CMC Documentation and patent writing.

·Successfully passed the cGMP audits from customer.

·Writing regulatory files in CTD format. Continuously support customer apply for preclinical, clinical phaseⅠ
　and phase Ⅱ. Now the project is in phase Ⅱb, and the process has been transfered to the manufacturer. 

·Now the project is about to enter phase Ⅲ.