If your company is based outside the EU/EEA, missing key PIP EMA milestones can mean trial delays, higher costs, and lost EU market opportunities before your pediatric program even starts.
A Paediatric Investigation Plan (PIP)—required by the European Medicines Agency (EMA) for most new medicines—sets out how you will study your product in children. It must be submitted and agreed with the EMA’s Paediatric Committee (PDCO) no later than completion of adult Phase I trials, and before initiating Phase II studies in the EU. Without expert guidance, PIP EMA submissions risk rejection, deferrals may be mishandled, and compliance checks can slow your path to market.
For non-EU/EEA developers, proactive PIP EMA management can be the difference between a smooth, on-time regulatory process and one stuck in avoidable delays.
Without expert PIP support:
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You risk PDCO (Paediatric Committee) rejections, leading to months of additional review
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Opportunities for deferrals or waivers can be missed
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EU incentives tied to pediatric compliance may be forfeited
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Regulatory timelines can slip due to incomplete or unclear submissions
Securing a well-prepared PIP EMA submission with the right EU-based partner turns a compliance risk into a strategic advantage.
We manage the full process—requirements check, strategy, authoring, submission via EMA’s IRIS portal, PDCO interaction, and post-approval modifications—so you can focus on development. From aligning with orphan drug or PRIME pathways to leveraging fee reductions, we ensure you capture every available regulatory benefit.
Result: A complete, compliant PIP EMA application submitted quickly and accurately, giving you the best chance of an efficient EMA review—without the need to open an EU entity.
Submission-ready in as little as 2–3 weeks — so your EMA review can start without delay.
