Regulatory Approval Consulting

Navigation through the FDA and European Regulatory Maze

A key element to successfully bringing your drug to market is an understanding of how to navigate the regulatory agencies in the U.S. and Europe.

To prevent unnecessary delays – which extend timelines and increase costs – it’s vital to have an effective regulatory approach and prepare a strong regulatory submission.

The Medelis team can provide flexible services ranging from answering specific regulatory questions, to writing, compiling and filing regulatory submissions, to setting up and leading regulatory meetings on your behalf.

Whether it’s higher-level regulatory activities, or collecting regulatory documents and preparing submissions, the Medelis regulatory experts can assist you by charting the straightest course through the regulatory maze.

Value to Sponsors

Having the right regulatory approach, and anticipating any potential issues before your regulatory submission, provides you with:

  • A reduced risk of regulatory delays
  • Assistance with collecting and preparing study-specific SOPs and regulatory documents
  • Comfort that you’re delivering strong regulatory submissions over the lifetime of your product
  • A potentially lower cost of study resulting from a straight path through the governing entities

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