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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