- Represented a multinational pharmaceutical company’s API manufacturing site in an FDA inspection and subsequent Form 483 response drafting, resulting in a VAI classification.
- Led an internal investigation of data falsification allegations by a whistleblower at a multinational pharmaceutical company’s aseptic processing site.
- Assisted a multinational medical device company’s internal investigation of its overseas CMO’s CGMP violations.
- Served as FDA counsel in a BPCIA patent litigation involving biologic drug, Enbrel®. Immunex Corp. et al. v. Sandoz (D. N.J.).
- Advised a NASDAQ-listed biotechnology company on strategic reorganization to reduce FDA enforcement risks.
- Represented a multinational plasma products manufacturer in China’s NMPA inspections and subsequent response drafting and corrective actions.
- Represented pharmaceutical and medical device companies in collaboration and licensing transactions, including contract manufacturing and quality agreement drafting.
Associate,
- Phone: 202.239.3036
- Email: zimu.yang@alston.com
Zimu Yang counsels domestic and overseas pharmaceutical, biotechnology, and medical device companies on a range of FDA regulatory, compliance, and enforcement matters.