Supporting Compliance with the Pediatric Research Equity Act (PREA)

Planning for your pediatric program and regulatory committments can be challenging.  Early planning for pediatric protocols should be a part of your overall Clinical Plan.  We can support compliance with the  FDA Pediatric Research Equity Act and all aspects of your clinical pediatric plan including:

  • US FDA required Pediatric Study Plan (PSP)
  • EU EMA required Paediatric Investigation Plan (PIP)
  • Protocol development, including relevant endpoints, age groups
  • Product specific waivers or deferrals