Having difficulty understanding the regulatory process for medical marketing authorization?

We can help

  • Authored by: Mark DuVal
  • Published on: June 29, 2018

Are you having difficulty understanding the regulatory process for medical marketing authorization?

We can assist you through every phase, from strategy development, to responding to FDA, and beyond. Make sure you've covered everything by checking your protocol against some of the areas we help clients with most frequently:

  • Regular Strategy Development

    • Classification pathways
    • Agency communication strategies
    • Intended Use strategy
    • Claims development
  • Pre-Sub

    • Advocating for regulatory path
    • Proposing pre-clinical and clinical data
    • Building relationship with FDA
  • Submissions

    • IDE
    • 510(k)
    • DeNovo
    • PMA
    • HUD-HDE
    • Combination products
  • Responding to FDA

    • Deficiency responses
    • Additional information requests
    • Additional information requests
    • Appeals
    • Submission issues meetings
    • Negotiating conditions of approval
The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM