Drug Development Strategy

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

REGULATORY ROADMAP

RPN supports in the definition of a development strategy and the related regulatory roadmap capturing all the activities that can significantly increase the value of your product in front of potential investors and partners, while taking you closer to marketing authorisation, potentially shortening the time to market.

GUIDANCE TO CLINICAL PHASE

In the early stages, RPN provides guidance in finding the optimal approach to design the clinical phase based on pre-clinical data by contemplating both Regulatory and Market Access objectives to meet the expectations of both Regulatory and HTA authorities.

EARLY ASSESSMENTS

In this phase, RPN also helps to assess the feasibility for orphan drug designations (ODD), to plan the right paediatric strategy, to apply for EU incentives to SMEs and to generate a smooth early dialogue with the Authorities through scientific advice, covering quality, preclinical and clinical aspects.

Pharmaceutical & BioTech