To support the authorization of drug products, in most cases a drug development company is required to prepare and submit a Paediatric Investigation Plan (PIP – EMA) or Pediatric Study Plan (PSP – FDA).
These plans are intended to support safe use of the drug in children.
Our consultants can assess the right conditions/ indications that should be studied. Additionally, they can evaluate (partial) waiver or deferral options, interact with agencies in case of Paediatric Scientific Advice, act on your behalf to coordinate the full procedure, and represent you at meetings with the Health Authority.
Our offering also includes the preparation and submission of follow-up activities such as PIP modifications and annual reports.