Pediatric Investigation Plan (PIP)

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Drug Development

Drug Development Strategy Gap Analysis SME Status Orphan Drug Designation (ODD) Scientific Advice Pediatric Investigation Plan (PIP) PRIME (PRIority MEdicines) scheme CMC Regulatory solutions Clinical Trial Application (CTA) Due Diligence

Regulatory Affairs

Registration Strategy Marketing Authorization Application (MAA) CMC Regulatory solutions Dossier Development Life cycle management Due Diligence Launch readiness Advertising & Promotion

Market Access

Early Access Programs Market Access Strategy Pricing & Reimbursement Dossier Health Economic Models Negotiation with Health Authorities Pricing & Reimbursement maintenance Joint Clinical Assessment (JCA) Integrated strategy and execution in the European markets

Pharmacovigilance

QPPV Services EudraVigilance services Pharmacovigilance System Master File (PSMF) Local Pharmacovigilance

Quality & Compliance

EMA REQUIREMENT

The European Union requires the development and submission of a Pediatric Investigation Plan (PIP) soon after Phase 1 studies are completed.

The PIP decision is also an integral part of the Marketing Authorization Application (MAA). This aims to facilitate the development and availability of medicines for children.

REGULATORY ASSISTANCE

RPN provides customized regulatory assistance on PIP development and submission, including:

Advice on the approach for PIP, deferral, and/or waiver applications.
Regulatory and scientific writing support for the preparation of the relevant documentation, submission, and follow-up of the PIP application.
Communications/meeting with the Pediatric Committee (PDCO).

Pharmaceutical & BioTech