Practice/Organization Description
Gardner Law provides legal and regulatory counsel to medical technology and pharmaceutical companies on FDA, anti-fraud and privacy matters. Our experienced staff have worked in industry or in the government. We provide practical advice to leaders around the world at all stages of the product life cycle, from ideation, R&D, clinical testing and regulatory submission, to manufacturing and commercialization.
Representative matters involve:
Reimbursement program compliance auditing and monitoring
FDA approval pathways, quality and regulatory assessments
Compliance assessments
Compliance programs, investigations, & training
Advertising and promotion review
Guidance on interactions with healthcare professionals
Government enforcement
Government reporting
Clinical research
Privacy matters
The Gardner Law team is comprised of eighteen (18) lawyers, consultants, and administrative staff with experience at organizations such as Johnson & Johnson, Bayer, Medtronic, 3M, Boston Scientific, Coloplast, Abbott, St. Jude Medical, Allergan, Genentech, United Health Group, the U.S. Food and Drug Administration (FDA), state government, among others.
