Gardner Law Provides Regulatory Counsel to Medical Technology and Pharmaceutical Companies.
Pharmaceutical, medical device, diagnostic, and biotechnology companies operate in one of the most highly-regulated business sectors in the world. Executives face a daunting challenge when it comes to seeking regulatory clearance or approval from the FDA, protecting their intellectual property, attaining financing, manufacturing their products, and distributing them. Gardner Law assists clients with the regulatory aspects of this journey.
The singular focus of Gardner Law is advising business leaders on regulations that impact their business. The firm provides cradle to grave advice, ranging from research and development, to clinical testing and regulatory submission, to eventual manufacturing and commercialization. The firm supports day-to-day and strategic business activities of clients by addressing and helping to manage regulatory risks.
COMBINED INDUSTRY AND LEGAL EXPERIENCE ALLOWS GARDNER LAW TO PROVIDE RESPONSIVE, STRATEGIC, AND PRACTICAL ADVICE TO INNOVATIVE COMPANIES SEEKING TO IMPROVE PATIENT LIVES.
What do companies that compete in FDA-regulated industry expect?
They expect outside counsel that not only understands the evolving laws and regulations and how they are applied by regulators, but more importantly, how they impact their business, i.e., the delivery of lifesaving and sustaining products.
Gardner Law was founded by Mark Gardner, M.B.A., J.D., to address the complex and evolving regulatory demands placed on pharmaceutical and medical technology companies. The mission of the firm is to support FDA-regulated industries in accomplishing their business goals in a fashion that complies with the law, including FDA and FTC regulations, fraud and abuse laws, disclosure laws, and privacy laws.
Mark founded the firm after working in industry and in private practice for 17 years, first as a marketer and later as an attorney. Prior to practicing law Mark worked in commercial roles at ev3 (Covidien-Medtronic), Celleration (Alliqua) and MedTox (LabCorp). In his time as a lawyer, Mark has counseled nearly 300 clients on regulatory matters.
Main practice areas include:
- Food, Drug and Cosmetic Act
- Anti-Kickback Statute
- False Claims Act
- Physician Payments Sunshine Act
- State reporting and compliance laws
- Foreign Corrupt Practices Act
- Stark Law
- Federal Trade Commission Act
- Public Health Service Act
- PhRMA, AdvaMed, and ACCME codes
Representative matters include:
- Leading the compliance function via day-to-day counsel to business leaders and managers
- Serving on promotional review (Medical, Legal, Regulatory) teams
- Serving on Scientific and Medical Review Committee (SMRC) Teams
- Training staff on various compliance and regulatory topics
- Performing compliance audits and investigations
- Designing and implementing compliance programs and policies
- Responding to regulators and competitors
- Resolving government enforcement actions
- Performing regulatory assessments
- Making FDA submissions
- Quality System Management services and remediation