Integrated strategy and execution in the European markets

Our services along the whole product lifecycle

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Discover all our Market Access services

Drug Development Regulatory Affairs Market Access Pharmacovigilance Quality & Compliance Case Studies

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

A TOP-TIER CONSULTING NETWORK

RPN offers a well-coordinated European market access solution through its EU Network of highly-specialized consulting agencies with solid experience in delivering
a winning launch across Europe.

Its goal is to support international and ambitious healthcare clients who expect a fast and successful market access and pricing strategy for the launch of their innovative products in Europe.

SYNERGY FOR HTA REGULATION

Through the EU network, RPN combines in-depth knowledge about European market access requirements as well as about local markets and stakeholders.

Moreover, the new HTA regulation (applicable from January 2025) involves a joint clinical assessment at the European level but maintains pricing and reimbursement negotiations and decisions at national level.
This makes the synergies generated by the EU network of paramount importance.

Pharmaceutical & BioTech