The Human

Super human powers.

Gardner Law counsels FDA-regulated companies with the human factor. Empathy, passion and listening are just some of critical everyday skills we use to build trust and confidence. Our positive energy is contagious, and our expertise is recognized. Gardner Law is fluent in the complex language the FDA speaks. We understand how to simply "walk the walk" past the many regulatory pitfalls. Focus, experience and specialization in a specific subject matter, matters. We call these skills our simple superpowers when making timely and effective regulatory submissions, filings, and negotiating with regulators.

Representative Matters Include:

  • Regulatory opinions
  • Product approval pathway assessments
  • 510(k)
  • Emergency Use Authorization (EUA)
  • Premarket Approval (PMA)
  • Pre-IDE
  • De novo
  • Humanitarian Device Exemptions (HDE)
  • Requests for Designation
  • Combination Product
  • IND
  • Pre-IND
  • ANDA
  • Orphan Drug
  • 505(b)(2)
  • Pre-Submission meetings
  • Panel meetings
  • FDA meetings
  • Negotiating clinical trials
  • Negotiating labeling
  • Reviewing research activities, e.g. advertising and recruitment practices
  • Modifications
  • CE Marking
  • CER filing
  • Appeals and Citizen Petitions
  • Promotional Review