Product research and development can be full of unexpected twists and turns.  The data expectations of the regulators is one of many potential stumbles,  HPM has the experience to help companies avoid regulatory surprises, get product development programs back on track, and identify efficiencies in their development strategies while still meeting regulatory requirements.  We put a premium on relationships, which is why we have worked hard to build strong relationships within FDA.

We assist clients with understanding the data required for marketing authorization of a product and discussing these issues in agency meetings.

  • HPM advises clients on everything necessary to obtain premarket approval from FDA, including:
    Requirements for Investigational Products (INDs and IDEs)
  • Clinical Studies and Clinical Holds
  • Marketing Authorizations for all FDA regulated products
    • Medical Device Premarket Notifications (510(k)s)
    • De Novo Petitions
    • Premarket Approval Applications (PMAs)
    • New Drug Applications (NDAs)
    • Biological License Applications (BLAs)
    • New Animal Drug Applications (NADAs)
    • Food Additive Petitions (FAPs)
    • Color Additive Petitions (CAPs)
  • 513(g) Requests
  • Meetings with FDA
  • Product Reclassification
  • Orphan Products (Orphan Drugs, Humanitarian Devices, Minor Use/Minor Species Drugs)
  • Product Approval Strategies
  • Preparation for FDA Advisory Committee / Advisory Panel meetings
Professionals