The RC Insight Group

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What We Do Best

On your behalf, we can provide the following:

  • Prepare global regulatory and clinical strategy to ensure a holistic approach to clinical trial planning and final commercialization, including:
    • Regulatory intelligence and market analysis
    • Global regulatory and clinical plan development
    • Clinical trial design as well as clinical trial implementation and management
    • IDE/IND FDA presub meetings and applications
    • 510(k), De Novo, and PMA submissions
    • CE Mark Technical File and Dossier compilation
    • CB Scheme testing requirements analysis
    • Import/export certification
       
  • Advise on international regulatory requirements and ensure data generated in support of an application meets these requirements
  • Serve as Official Correspondent for FDA submissions
  • Serve as US Agent with the FDA
  • Interact and manage meetings with regulatory agencies to seek advice, agreement, and approval
  • Provide regulatory due diligence evaluations of products or corporate acquisitions




 

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