中文 English FOllOW US: logo

Regulatory CMC


Regulatory CMC

FacebookTwitterLinkedInEmail

 Full CMC packages for IND submission are composed by a dedicated technical writing group

  • For global and China 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

 

Case

ASU CASE 1 EN 1214-1