Services

REGULATORY AFFAIRS

CDMO assists you to navigate complex regulatory processes and advance your program into the clinical and commercial. The team has years of experience in biological and our global RA expertise offers comprehensive services with deep understanding of global regulations and extensive experience in IND\IMPD and BLA filing for biological drugs and biosimilars.

• Regulatory filing strategy and execution
• Meetings (pre-IND/EOPⅡ/Pre-BLA) with agency and investigational applications (IND/IMPD/CTA), amendments and supplements
• Marketing applications (BLA-PHSA 351(a)/ 351(K)/MAA)
• Support for regulatory dossier submissions around the world in both eCTD and non-eCTD formats:
  • eCTDs writing, formatting and submitting

CMC Strategy, Management and Communication

• Drug development CMC strategy consulting
• CMC gap analysis