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Paediatric investigation plan (PIP) applications

  • Advise on the approach for PIP, deferral and/or waiver applications, according to the Paediatric Regulation
  • Support for the preparation of the relevant documentation, submission and follow-up of PIP application
  • Communications/meeting with the Paediatric Committee (PDCO)

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Old molecule for a new indication an Assion case study

A US start-up business, specialising in the field of gastroenterology, was looking to repurpose an old molecule for a new indication encompassing a different route of administration.