RCRI supports clients through all phases of product development, including:

  • Regulatory and clinical strategy
  • Study design and statistical analyses
  • FDA/regulatory body negotiation
  • Clinical study operations
  • Health economics & reimbursement
  • Quality systems
  • Compliance

From simple modifications of market-released products to novel combination products, RCRI’s deep expertise and proven approach removes obstacles, expediting regulatory approvals with major regulatory agencies and notified bodies around the globe.

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Regulatory and Clinical Research Institute

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