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