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)
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.