Mark Gardner, M.B.A., J.D., Directing Attorney
Email mgardner@gardner.law
Office 651.430.7150
Mobile 612.382.7584
Mark Gardner has provided regulatory counsel to over 500 FDA-regulated companies across the U.S., Canada, Europe, Japan, Australia and Israel. He uses over 20 years of experience to counsel and train clients on compliance, product approvals, ad/promo review, enforcement actions, sunshine reporting, quality and regulatory matters, and privacy. Prior to practicing law he worked in commercial roles at ev3 (Medtronic), Celleration (Alliqua), and MedTox (LabCorp). He is an Adjunct Professor of Law and HLI advisory board member at Mitchell Hamline School of Law.
Clients Counseled
Ski Areas Visited
Executives today face a more rigorous and demanding regulatory environment than those that preceded them. My clients appreciate my prior industry experience and how I apply it in my practice. Since I’ve walked in the shoes of my clients, I know what they are going through. I can relate to their business objectives and help them achieve them in a compliant fashion. This is what sets me apart from other lawyers.
– MARK GARDNER, M.B.A., J.D.
Practice Areas:
- Compliance assessments, investigations and training
- Design and implementation of compliance programs
- Advertising and promotional review
- Business interactions with health care professionals
- Responding to and negotiating with the FDA and DOJ
- Transparency reporting
- Quality and Regulatory assessments
- Product clinical investigation and FDA approval pathways
- Privacy compliance
- Responding to and negotiating with the government