Paediatric Planning & Documentation

The PIP is a required element for new drugs – both the FDA & EMEA need to see that the paediatric population has explicit consideration within the product development plan. A PIP must be agreed with the regulators prior to the commencement of validation of the marketing authorisation application.

Peritus Regulatory support:

• Advice on formulating the PIP
• Nonclinical & pharmacological inputs into PIP
• Management of the PIP application