Regulatory Support

Regulatory Submissions


Services include developing submission template/table of contents, writing, reviewing, editing of submissions. It also includes assisting with FDA, Regulatory Agency and Notified Body communications through the submission review process.


     FDA Submissions:

  • PMA: Original, Modular and PMA Supplements
  • Original IDE and IDE Supplements
  • 510(k): Traditional, Abbreviated and Special 510(k)s
  • HUD and HDE applications

     International Submissions:

  • CE Mark: Technical files and design dossiers
  • Health Canada and Japan PMDA applications

      Combination products:

  • IND/IDE
  • NDA/PMA

       IVDs:

  • 510(k)s, PMAs for High Complexity kits
  • CMS’ CLIA, NY and other state agency requirements