Pharmablue / Paediatric Investigation Plans (PIP)
A paediatric investigation plan (PIP) is a development plan intended to support the authorisation of a medicine for children by ensuring data are obtained through studies in the paediatric population.
Our consultants can advise as to whether a deferral or waiver may be appropriate and can provide a complete PIP writing service as well as any PIP modifications through the lifecycle of the product within the EU or US.
Scientific advice and Interaction with Health Regulatory Agencies
Orphan Drug Designations (ODD)
Advanced Therapy Medicinal Product (ATMP)
Early Access Programmes