Marketing Authorization Application (MAA)

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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 GUIDE THROUGH DIFFERENT PROCEDURES

There are several procedures available to register pharmaceutical drugs in the EU:

Centralized procedure, mandatory for specific product categories (e.g. orphan drugs).
Mutual Recognition Procedure (MRP) or the Decentralized Procedure (DCP).
National procedure.

Before the preparation of an MAA, RPN assists in developing a strategy to coordinate the generation of the needed documents and related procedures. A gap analysis is frequently embedded in the early phase of the process to highlight any potential issues with the draft dossier or the intended submission strategy.

EXPERTISE IN INTERNATIONAL AND LOCAL PROCEDURES

RPN combines capabilities at both the international and local levels so as to establish smooth communications with EMA and/or National Competent Authorities during the assessment of the MAA procedure and to drive faster approvals.

SUPPORT AT EVERY STAGE

RPN provides support for its clients at every stage of the MAA: writing, review, and submission of all modules required, oversight of the procedure throughout the assessment phase until the authorization is complete.

Pharmaceutical & BioTech