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