JFK Communications understands the rigorous global regulatory environments life science companies must operate under.  The partnership between commercial sponsors and regulatory authorities result in naturally occurring milestones.

JFK Communications is very familiar with these regulatory milestones and helps its life science clients calendarize and maximize the opportunities and minimize the threats created by these milestones.

We offer expert advice regarding key regulatory events, such as:

  • IND applications/acceptance
  • Acceptance of clinical trials; clinical trial launches; patient recruitment
  • Filing products with local/national regulatory agencies (NDA, aNDA, OTC, BLA, 510K, PMA, etc)
  • Acceptance of filing
  • Withdrawal of filing
  • FDA advisory committees
  • Regulatory clearances
  • Expanded access/compassionate use
  • Named patient programs
  • Compliance violations
  • Data communications; publication support
  • Clinical Trial Support
FDA Approved FDA Cleared European Medical Agency

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