Anna Zhao advises clients on a broad range of regulatory, compliance, transactional, and legislative matters in the life sciences industry. She focuses on counseling pharmaceutical and biotechnology companies and industry associations on clinical trials, informed consents, regulatory applications and approvals, FDA expedited programs, orphan-drug exclusivities, promotion and scientific exchange, quality and manufacturing, and priority review vouchers.
Drawing on her regulatory knowledge and expertise, Ms. Zhao regularly assists clients with mergers and acquisitions, capital market transactions, and life sciences collaboration and licensing matters and various agreements and filings that are often associated with these transactions. As part of her transactional practice, Ms. Zhao advises clients on assessing regulatory risks and mitigating them to achieve commercial objectives.
In addition, Ms. Zhao represents clients in complex government enforcement actions and internal investigations on a variety of issues, including clinical trial, manufacturing, and marketing and sales compliance issues.
Ms. Zhao is qualified to practice Chinese law, admitted to practice in the State of New York, and licensed in the District of Columbia as a Special Legal Consultant.