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Amy Leiser
Washington +1 202 662 5916 aleiser@cov.com Download V-card

Amy Leiser is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device group. She advises pharmaceutical, biotechnology and device companies on a variety of regulatory and compliance issues.

  • Advise on compliance with ClinicalTrials.gov registration and reporting requirements.
  • Advise on regulatory compliance issues regarding drug listing.
  • Advise pharmaceutical company on regulatory strategy for clinical stage biological product.
  • Draft white papers regarding application of FDA’s expedited programs.
  • Conduct international surveys regarding regulation of biosimilar products and medical devices.
  • Draft advocacy letter regarding implementation of biological reference product exclusivity law and draft request for reference product exclusivity.
  • Conduct internal investigation of pharmaceutical company’s computerized system data management practices.
  • Advise on development of quality agreements and quality agreement templates for contract manufacturing of drugs and biologics.
  • Draft responses to foreign and domestic health regulatory authority enforcement letters.
  • Support regulatory due diligences for medical products companies.

Pro Bono

  • Represented Federally Qualified Health Center (FQHC) in preparing public comments concerning FDA blood donation guidelines.
  • Advised non-profit organization on redistricting laws and procedures in various states.
  • Conducted survey of state Medicaid and prescriptive authority laws for health care non-profit.
  • Represented national advocacy organization in judicial vetting matter.
  • Successfully represented individual seeking criminal record expunction in Maryland.

Previous Experience

  • Merck & Co. Inc., Associate Specialist, Engineering (2012-2013)
  • Washington DC Super Lawyers Rising Star, Food and Drug (2019)