Gardner Law counsels drug and device companies on laws and regulations that impact their business.
Industry experience sets Gardner Law apart.
We help you identify and mitigate regulatory risk.
Experience matters when interacting with the government.
We help you achieve your objectives in a compliant fashion.
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.
Gardner Law provides opinions on the impact of the law on Marketing, Sales, Reimbursement, and Clinical programs.
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.
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.
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.