CMC Regulatory solutions

Our services along the whole product lifecycle

Services by stage

Discover all our Drug Development 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 KEY MILESTONE

The CMC (Chemistry, Manufacturing and Control) section represents a key component of the clinical trial, of the Marketing Authorization Application, and of the post-approval strategy.

RPN addresses the broad spectrum of regulatory and technical aspects of CMC, taking into consideration the specific product complexity, its stage of development, and the advancing quality and regulatory environment.

A COMPREHENSIVE RANGE OF SOLUTIONS

RPN solutions in the CMC Regulatory area comprise:

Strategic advice on CMC development
Support in the preparation of CMC sections of IMPD/IND, MAA/NDA, BLA
Assistance for scientific advice procedures on quality topics
EU/US Gap Analysis and adaptation
Support in the selection of CMOs
CMC assistance for post-approval maintenance
Due Diligence on CMC aspects

Pharmaceutical & BioTech