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

Gardner Law staff possess hands-on industry experience which they use to provide efficient, practical and responsive advice to those keen on saving and restoring lives.

Pharmaceutical, medical device, diagnostic, digital health, 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 regulatory bodies like 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.

We help clients address and manage regulatory risk and expedite the time it takes to get to market. We provide advice at all stages of the product life cycle from ideation, to research and development, to clinical testing and regulatory submission, to manufacturing and commercialization.

What manufacturers expect?

They expect 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.

Areas we specialize:

  • 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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