Gardner Law specializes in regulatory counsel for medical technology and pharmaceutical manufacturers.

Our attorneys have worked in the medical device and/or pharmaceutical industries — which sets them apart from other lawyers. Every day we strive to provide practical and responsive advice to manufacturers of life saving and restoring products.

Gardner Law serves pharmaceutical, medical device, diagnostic, digital health, biotechnology, and laboratory companies across the U.S., Canada, Europe, Japan, Australia and Israel. Our clients operate in one of the most highly-regulated business sectors in the world. We help them address and manage regulatory risk and expedite the time it takes to get a new product to market. We provide advice at all stages of the product life cycle from ideation, to R&D, to clinical testing and regulatory submission, to manufacturing and commercialization.

What can manufacturers expect?

With Gardner Law, they’ll get outside counsel that understands evolving laws and regulations and how they are applied by regulators to the delivery of life-saving and life-sustaining products.

Our areas of specialty:

  • Compliance assessments, investigations and training
  • FDA approval pathways
  • Design and implementation of compliance programs
  • Advertising and promotional review
  • Business interactions with healthcare professionals
  • Responding to and negotiating with the government
  • Sunshine reporting
  • Quality assessments and remediation
  • Answering complex regulatory questions
  • Clinical research compliance
  • Healthcare privacy
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