Who is Gardner Law?
Gardner Law specializes in laws and regulations that govern the development and commercialization of pharmaceuticals and medical technologies. The firm provides practical and responsive counsel to company leaders navigating today’s regulatory minefield.
COMPLIANCE
Gardner Law provides opinions on the impact of the law on Marketing, Sales, Reimbursement, and Clinical programs.
ADVERTISING & PROMOTION REVIEW
The firm counsels clients on matters involving the labeling, advertising, and promotion of FDA-regulated products.
SUNSHINE REPORTING
Clients turn to Gardner Law for assistance with the Physician Payments Sunshine Act (“Sunshine Act”) and similar state laws.
GOVERNMENT ENFORCEMENT ACTIONS
Gardner Law helps clients respond to and resolve FDA and DOJ inquiries and enforcement actions.
CLINICAL SERVICES
The firm has extensive experience with the regulatory issues that impact clinical research activities.
FDA REGULATORY
Gardner Law is experienced in making submissions to the FDA and in helping clients meet Quality Management System requirements.
About
Gardner Law was founded by Mark Gardner to help industry executives succeed in the face of ever-changing legal and regulatory requirements. The regulatory risks and obligations faced by companies and executives today are more severe and onerous than ever before.
Mark worked in business in various commercial functions before practicing law. He has personally experienced the challenges faced by the medical and pharmaceutical industries, and that experience sets Gardner Law apart from other law firms.
Industries Served
Gardner Law only represents companies that are regulated by the FDA.
The firm primarily serves the medical device, pharmaceutical, biotech, and diagnostic industries. However, Gardner Law also has experience with other FDA-regulated industries, including HCT/Ps, dietary supplements, food and cosmetics.
News
Gardner Law associates write and speak about legal and regulatory issues that impact FDA-regulated industries, and are quoted by the media.
The firm participates in conferences on topics such as off-label promotion and lawful dissemination methods, social media use, effective compliance programs and audits, mobile medical applications, Sunshine reporting, enforcement trends (FDA, OIG, & DOJ), and the FDA approval process.
MISSION
Helping clients achieve their business goals in a compliant and efficient fashion.
VISION
To be recognized as a preeminent provider of legal counsel and regulatory services for FDA-regulated companies.
VALUES
Gardner Law was built on integrity, reliability, collaboration, pragmatism and dynamism. Exceptionally professional and always ethical, the firm gives back to the communities it serves.