PRACTICE AREAS

FDA Regulatory Submissions and Quality System Services

We have extensive experience making FDA submissions, designing and administering Quality Management Systems, and remediating quality issues.

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Clinical Services

We have extensive experience with clinical activities.

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Compliance

We regularly provide counsel regarding the impact of laws and regulations on Marketing, Sales, Health Economic/Market Access, Medical, and Clinical activities.

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Advertising and Promotion Review

Gardner Law counsels clients on how to label, advertise, and promote FDA-regulated products.

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Government Enforcement Actions

Gardner Law represents clients dealing with FDA and DOJ enforcement actions.

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Federal and State Disclosure and Compliance Laws

The firm has extensive experience with new transparency requirements including the Physician Payments Sunshine Act (“Sunshine Act”) and state laws’ analogs.

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ABOUT THE FIRM
Gardner Law Logo

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 the regulatory minefield which they face today.

CONTACT
  • 423 Main Street South
    Stillwater, MN 55082
  • 612.382.7584
  • 651.430.7150
  • office@gardner.law
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