Regulatory guidance is a critical component of a successful product development program.

At MSC, we understand how to navigate the international regulatory landscape to expedite product approvals. MSC offers a variety of operational and strategic consulting services to facilitate interactions with regulatory agencies and IRBs/ethics committees.

Regulatory Affairs services include:
  • Clinical development planning
  • Pre investigational device exemption (Pre-IDE)
  • Investigational device exemption (IDE)
  • Pre-market notification (510k)
  • Pre-market approval application (PMA)
  • Humanitarian device (HUD)
  • Humanitarian device exemption (HDE)
  • Clinical Evaluation Reports (CER)
  • Summary of Safety & Effectiveness Data (SSED)
  • Labeling
  • Clinical study reports
  • Reimbursement strategies
  • Agency audit support and warning letter resolution
  • SOP development
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