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