Regulatory Affairs

WuXi Biologics provides a large, experienced and dedicated regulatory affairs team to support your drug filing and registration efforts. We have consulted, provided the requisite documentation or helped write either partial or in-full over 135 IND/CTA CMC sections for our clients and partners in the last 5 years.

Regulatory CMC Advisory Services
Regulatory Submission Support Services
Regulatory Intelligence

Dedicated regulatory CMC advisory services
Continuous support throughout entire product development life cycle for each integrated project
Regulatory CMC strategy and gap analysis for single or multi-regional filings including U.S., EU, China and other major markets
Guidance and feedback to achieve fastest regulatory pathway while minimizing risks and maintaining quality
Expert partner to navigate the rapidly evolving regulatory landscape in China

Comprehensive expertise for eCTD compatible CMC dossier preparation
Write and/or review entire Module 3 CMC sections and Module 2 CMC Summary for IND/CTA/BLA/MAA/NDA/DMF
Flexible and customized preparation services
Timely support to respond to inquiries and questions from regulatory authorities
Regulatory meeting support and preparation (briefing book, technical advice, strategy)
Dossier updates, amendments, and post-approval support

Comprehensive expertise for eCTD compatible CMC dossier preparation
Write and/or review entire Module 3 CMC sections and Module 2 CMC Summary for IND/CTA/BLA/MAA/NDA/DMF
Flexible and customized preparation services
Timely support to respond to inquiries and questions from regulatory authorities
Regulatory meeting support and preparation (briefing book, technical advice, strategy)
Dossier updates, amendments, and post-approval support