Regulatory Affairs

To support your drug filing and registration efforts, WuXi Biologics provides a large, dedicated and highly experienced regulatory affairs team integrated into our comprehensive Contract Research, Development and Manufacturing Organization (CRDMO) services and Quality functions. We have supported, consulted and provided the requisite documentation for over 300 INDs/CTAs and over 20 different BLAs / MAAs / NDAs / EUAs and have written, in-full, over 150 Module 3 CMC packages for our clients since we first established our regulatory affairs unit in 2015.

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 the U.S., EU, China, Japan, Australia, Canada, Singapore, Korea and other major markets
Guidance and feedback to achieve the 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 / EUA / 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

Provide global regulatory updates and newsletters for both internal staff and our clients (see below for more information)
Dedicated teams that monitor the latest regulatory trends and landscape in China and other international markets
Continual information and notifications on trends and developments, including updates on regulatory CMC strategy

Regulatory Newsletter

On a quarterly basis, the WuXi Biologics’ Regulatory Affairs team provides a summary (in newsletter format) of the regulatory guidances that are either in draft or final status by agency and by topic. We have compiled these updates to support our clients’ efforts to stay current in the ever-changing regulatory environment for biological therapeutics and vaccines.

Click here – to see examples of our past Regulatory Newsletters

Click here – to sign-up and receive a reminder that a new Regulatory Newsletter is available