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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.

Food, Drug, and Device Regulatory Matters

  • Counseled pharmaceutical clients on clinical trials and drug approvals, informed consents, and orphan-drug exclusivity issues.
  • Advised pharmaceutical clients on cGMP compliance and quality issues.
  • Drafted policies and procedures on promotion and scientific communications for medical products.
  • Advised pharmaceutical clients on NDA and BLA filing issues. 
  • Advised pharmaceutical clients on interactions with healthcare professionals.
  • Conducted FDA regulatory review for UCB in its $2.1 billion acquisition of Ra Pharmaceuticals.
  • Conducted FDA regulatory review for Merck in its $2.7 billion acquisition of ArQule; $1.05 billion acquisition of Peloton Therapeutics; and $425 million acquisition of OncoImmune.
  • Advised Bayer in its sale of Coppertone business Beiersdorf AG and Dr. Scholl’s business to Yellow Wood Partners.
  • Counseled business on managing the life cycle of pharmaceutical products.    

White Collar Defense and Investigations

  • Represented a major pharmaceutical company in numerous internal investigations concerning sales and marketing practices.
  • Represented a major financial institution in government investigations of foreign bribery relating to hiring practices.
  • Represented an employee at a major bank on issues arising under the False Claim Act.

International Trade and Investment

  • Advised companies and business associations regarding commitments of foreign governments under World Trade Organization (WTO) rules and free trade agreements.
  • Advised a leading payment card association on the WTO dispute settlement proceedings and electronic payment services regulations in China.
  • Assisted various clients in analyzing Chinese government’s approval process and restraints on foreign investment.

Memberships and Affiliations

  • American Bar Association
  • New York State Bar Association
  • Association of Certified Fraud Examiners
  • Sino-American Pharmaceutical Professionals Association