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 370 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.
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