Regulatory Support

• Regulatory Support

  We work for our client in order to get their product on the market efficiently and effectivly.

  We provide a full range of regulatory support service, with particular focus to:

  • Technical File / Design Dossier
  • Design Control
  • DHF Design History File
  • Risk Management Process
  • Clinical Evaluation
  
  Our regulatory expertise includes regulatory consultants and scientists who have extensive experience dealing with Autorities of U.S. and EU.

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