Darya Lucas
Associate Attorney

dlucas@gardner.law
O: 651.430.7150
M: 651.374.9015

Darya Lucas advises medical device and pharmaceutical companies on FDA regulatory strategy across the product life cycle. Her practice focuses on supporting FDA submissions, lifecycle compliance, and promotional review. Clients rely on Darya for detail-oriented regulatory support that aligns compliance requirements with development and commercialization timelines.

Darya supports preparation and review of regulatory submissions, including drafting sections of premarket applications and coordinating technical documentation. She assists clients in maintaining compliance throughout product lifecycle changes, including labeling updates and post-market reporting obligations.

Her work includes detailed regulatory research and monitoring of agency developments to help clients anticipate shifts in FDA expectations.h.

Representative Experience

  • Regulatory Affairs
  • Clinical Research
  • Litigation
  • Transactional Agreements
  • Pro Bono

Education

  • Juris Doctor, Mitchell Hamline School of Law (St. Paul, MN)
  • B. A., Political Science and Minor, Biology

Bar Admissions and Qualifications

  • Minnesota