Global Life-Cycle Management

Our services along the whole product lifecycle

Services by stage

Discover all our Pharmaceutical & BioTech 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

Client Profile

A medium-sized multinational Pharma company with operations in US, EU, and Asia.

Executive Summary

RPN streamlined the global life-cycle management offering efficiency and cost savings, including standardized submissions and localized regulatory intelligence.
Strategic initial filing support to expedite market entry, coupled with a systematic approach for risk prediction in submissions and budgeting.
Enhanced regulatory operations across US, EU, and Asia to support business continuity, manage high-volume strategic projects, and ensure compliance.

Challenges

The client required global life-cycle management to enhance efficiency and achieve cost savings, necessitating standardized submission processes and sound local regulatory intelligence. The initial filing process was critical to accelerate the strategic go-to-market plan, requiring a systematic approach to foresee project risks, manage submission timelines, and adhere to the approved budget. Furthermore, regulatory operations needed bolstering across US, EU, and Asia to support ongoing business continuity and handle the volume of strategic projects, including new submissions and tool implementations.

Solutions

RPN provided comprehensive support by transitioning life-cycle management activities on a country-by-country basis, ensuring global efficiency. Our approach included:

Project Management: Implementing proactive and effective strategies to meet objectives within timelines and budgets.
Global Regulatory Intelligence: Gathering and analyzing data to develop robust regulatory strategies and support informed decision-making.
Strategic Planning: Allocating resources and coordinating activities to minimize risks and disruptions, ensuring optimal project success.
Tailored Capacity: Offering capacity tailored to the activities’ workloads varying during time.

Results

RPN’s impact was significant and measurable:

Global Reach: Successfully managed over 20 countries and 5 brands, thanks to our international deployment.
Network Utilization: Leveraged on the RPN Partner Network to support life-cycle management and initial filing activities globally, ensuring a seamless and integrated approach to regulatory compliance and market entry