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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