Life cycle management

Our services along the whole product lifecycle

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Discover all our Regulatory Affairs 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

SUPPORT TO SAFEGUARD INVESTMENTS MADE

Once the product has obtained approval, various modifications may arise that could potentially affect its registered information.

RPN provides guidance on the necessary actions to maintain compliance by identifying the impact and classification of changes, as well as developing submission strategies and supporting documentation for the different geographies.

Leveraging its comprehensive regulatory intelligence and extensive expertise, RPN helps safeguard the company’s investment by ensuring ongoing compliance and market presence throughout the products’ life cycles.

RPN closely monitors all submissions and approvals so to follow-up promptly with authorities in order to manage any change implementation. This is to ensure no disruption of product supply or out-of-stock issues.

VARIATIONS, RENEWALS, MARKETING AUTHORISATION TRANSFERS

Variations to a Marketing Authorization are necessary for various reasons: manufacturing changes, additional data generated, etc.

Changes are implemented via specific variation procedures and are subject to the approval of the European Medicines Agency (EMA) or National Competent Authorities (NCA) in the EU and other regions.

Variations in the EU follow a specific classification: type IAIN, type IA, type IB and type II variations or Article 61(3) notification. Each classification determines the length of the variation procedure and the detail of assessment that is required.

A Marketing Authorization in the EU must be renewed after five years.

A Marketing Authorization Transfer is the procedure by which the Marketing Authorization is transferred to a new Marketing Authorization Holder. The transfer generates changes to be implemented through relevant variation procedures.

STRATEGIC ADVICE AND OPERATIONAL EXECUTION

RPN combines strategic advice on:

variation classification and intelligence on local requirements (e.g., European grouping / super grouping and work-sharing procedures);
regulatory strategy to upgrade the dossier after a gap analysis or to submit the renewal application;
line extensions, legal switch applications

…with the relevant operational execution:

writing and submission of all types of variations (administrative, safety, CMC etc.), renewals, license transfers, and post-approval commitments, for all type of products;
support for the process of linguistic review and other translations.

Pharmaceutical & BioTech