WuXi Biologics
Offering End-to-End Solutions
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.
- 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