Early Access Programs

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

EMPOWERING PATIENT ACCESS

Patients can access drugs targeting diseases with unmet medical needs prior to launch through several mechanisms: Health Technology Appraisal (HTA) approvals, Pricing & Reimbursement (P&R) decisions and Early Access Programs (EAPs).

Early Access Programs differ among the European countries due to their specific national regulations.
RPN supports pharmaceutical companies in navigating the complexities of EAPs, structuring the activities related to their implementation and ensuring timely access to medicines throughout the drug’s clinical development, from Phase II to Phase III and beyond.

As treatments for life-threatening diseases advance rapidly, RPN’s expertise becomes increasingly valuable in providing compliant access to investigational drugs outside of clinical trials and in countries where the product may not be registered yet.

Pharmaceutical & BioTech