Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

PIP & PIP modification

For a global pharmaceutical company

A global pharmaceutical company engaged the services of BioVentures Consulting Limited to progress an oncology project towards an MAA via the EU Centralised Procedure, including as an essential element the paediatric development plan. A PIP application was submitted an opinion subsequently awarded. The client decided to apply for a modification to the agreed PIP in order to improve on the agreed deliverables. Following the letter of intent, BioVentures Consulting Limited personnel completed and submitted the revised EMA interactive PIP application form and appropriate documents for Annexes B to F within the 60 day timetables process. A revised agreement was reached and the services of BioVentures Consulting were retained to deliver on the agreements. The PIP is an important part of drug development, and is an area which is evolving from both the Agency and Industry perspective. BioVentures Consulting Limited maintains an on-going active involvement in this increasingly important aspect. The expertise and resource and time required to deliver a typical PIP strategy should not be underestimated.

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