Mark Gardner
Founder and Managing Partner
O: 651.430.7150
M: 612.382.7584
Mark Gardner is the founder and managing partner of Gardner Law, advising medical device, pharmaceutical, food, and life sciences companies on FDA regulatory strategy, compliance, enforcement response, and complex commercial matters across the product life cycle. With more than 25 years of experience, including senior in-house legal, regulatory, and commercial roles, he brings a pragmatic, business-oriented approach grounded in operational realities. Clients rely on Mark for high-stakes FDA interactions, enforcement response, due diligence, and strategic guidance that aligns regulatory compliance with commercial objectives.
Before founding Gardner Law, Mark served in senior in-house legal and regulatory leadership roles within medical technology companies, where he worked closely with executive teams, commercial leaders, and quality organizations. His experience includes leading internal investigations, responding to FDA warning letters and other agency actions, and managing regulatory diligence in mergers, acquisitions, and strategic transactions.
Mark regularly counsels boards and senior management on governance, compliance infrastructure, and enterprise risk management in FDA-regulated environments. He also speaks and writes on FDA enforcement trends, regulatory strategy, and the intersection of compliance and commercialization, offering clients perspective shaped by both outside counsel and operational leadership experience.
Representative Experience
- Remediate labeling and negotiate multiple consent decrees between dietary supplement companies, executives, FDA and DOJ.
- Perform court-ordered expert reviews and successfully petition FDA and DOJ to vacate injunction issued by consent decree for probiotic manufacturer.
- Testify as an expert witness in a food trial.
- Perform regulatory, compliance, and privacy due diligence on behalf of buyer acquiring a medical device company for over one billion dollars.
- Perform board-directed audit of drug company’s compliance function and lead subsequent remediation project.
- Serve as compliance officer for multinational manufacturer or drugs and medical devices.
- Counseled food companies on patient support programs and agreements with purchasers, pharmacies, and distributors in preparation for the launch of new products.
- Advise drug and device makers on compliance with aggregate spend reporting required under CMS Open Payments program (Physician Payments Sunshine Act), as well as state, municipal, and international requirements. Perform reporting on behalf of clients.
- Serve as chief compliance officer for drug manufacturer.
- Audit reimbursement support program for multinational device maker.
- Perform HIPAA compliance audit of DME maker.
- Negotiate thousands of CTAs with clinical trial sites on behalf of sponsors.
- Perform hundreds of compliance trainings.
- Resolve nearly every variety of FDA enforcement actions including 483s, warning letters, recalls, import refusals and holds, seizures, injunctions and CFG denials on behalf of manufacturers—several involving international matters.
- Serve on advertising and promotional review committee as legal or regulatory reviewer.
Education
- Juris Doctor, Mitchell Hamline School of Law
- Master of Business Administration, University of St. Thomas - Opus College of Business
- Bachelor of Science, Economics, Finance, University of Wisconsin - La Crosse
Bar Admissions and Qualifications
- Minnesota
Court Admissions
- U.S. District Court, District of Minnesota
Memberships
- Co-Chair, 2023 FDLI Advertising & Promotion for Medical Products Conference, Food & Drug Law Institute
- Council Member, Minnesota State Bar Association - Food, Drug and Device Law Section
- Council Member, Minnesota State Bar Association - Heath Law Section
- Member, Medical Alley
Faculty Appointments
- Adjunct Professor of Law, Mitchell Hamline School of Law - Drug and Device Law
- Senior Lecturer, University of Minnesota - Carlson School of Management - Healthcare Law: Strategic and Business Implications
- Adjunct Professor, University of Minnesota Law School - Food, Drug and Device Law