Regulatory CMC

The Analytical Service Unit provides regulatory CMC in support of global IND and NDA submissions, providing both standalone services and integrated packages to meet the specifications of each unique project.

+ Dossier preparation for global submission
+ Standalone CMC packages for IND and NDA
+ Regulatory consulting
+ Extraction and compilation of information from reports from WuXi or third parties
+ CTA/CTD format ready for filing
+ Version controls implemented for easy traceability
+ Translation service from English to Chinese or Chinese to English