Mark Gardner

Mark founded Gardner Law, an FDA law firm that specializes in regulatory, compliance, and privacy matters. Using his real-world in-house experience, combined with extensive private practice experience, which includes secondments with some of the largest healthcare companies in the world, Mark solves multifaceted legal challenges for clients in a practical fashion. His unique background in healthcare, which spans back to 1999, is used to evaluate industry practices against regulatory requirements, helping companies achieve business goals in a compliant fashion. His specialties include guiding clients through complex FDA matters, performing due diligence for buyers and sellers, assessing sales and marketing programs and commercial transactions, designing and implementing compliant ways to interact with healthcare providers, facilitating government transparency reporting, and auditing and investigating company activities for compliance with the law. Mark works with regulators at the FDA, CMS, and OCR, and with law enforcement at the DOJ and OIG. He teaches Drug & Device Law at Mitchell Hamline School of Law, Health Care Law: Strategic and Business Implications, at the University of Minnesota-Carlson School of Management, and Food, Drug, and Device law at the University of Minnesota Law School. He has founded several operating and holding companies in the healthcare space. He volunteers at FDLI, MSBA Food, Drug, & Device Law Sec., MSBA Health Law Sec., and Mitchell Hamline.