Mark Gardner, JD, MBA

Of Counsel

Mark Gardner specializes in providing regulatory counsel to medical technology and pharmaceutical companies. Prior to practicing law, he worked in product commercialization and development at ev3 (Covidien-Medtronic), Celleration (Alliqua), and MedTox (LabCorp). Mark is regularly invited to speak, nationally and internationally, on regulatory topics that impact the life sciences industry.
Mark counsels clients on how to mitigate and navigate the compliance risks presented by the Sales and Marketing functions. He performs compliance assessments and implements compliance programs, trains companies on how to interact with healthcare professionals, and provides counseling on how to avoid and respond to enforcement actions. Mark routinely performs investigations and negotiates with the FDA and the Department of Justice (DOJ) on behalf of clients. He has convinced the government not to escalate enforcement actions on numerous occasions.
In addition to teaching FDA law as an Adjunct Professor at Mitchell Hamline School of Law, Mark sits on the Advisory Board for the school’s nationally ranked Health Law Institute and is the school’s Health Law Regulatory Compliance Competition Coach. He also sits on the Section Council for the Minnesota State Bar Association Food, Drug, and Device Law Section, and has Co-Chaired the Medical Alley Regulatory Special Interest Group. Mark is a member of Medical Alley, the American Bar Association (ABA), and the Food and Drug and Law Institute (FDLI).