Pharmaceutical & BioTech
Discover all our Pharmaceutical & BioTech services
Drug Development
Regulatory Affairs
Market Access
Pharmacovigilance
Quality & Compliance
Regulatory Pathway for ATMP
Client Profile
A clinical-stage biopharmaceutical company focused on the development of orphan drugs and Advanced Therapy Medicinal Products (ATMPs).
Executive Summary
- Navigated the journey from preclinical/clinical development to marketing authorization and product launch.
- Implemented a strategic approach for early dialogue with regulatory authorities and management of the Marketing Authorization Application (MAA).
- Achieved marketing authorization, successful price and reimbursement negotiations, and efficient product launch and maintenance.
Challenges
The company faced challenges in transitioning from the preclinical and clinical development phases to obtaining marketing authorization and launching their products. This involved navigating complex regulatory environments and managing various aspects of product registration and market entry.
Solutions
RPN provided comprehensive support through various stages:
- Development Phase: Engaged in early dialogue strategies with the EMA and national authorities, provided protocol assistance, and secured orphan drug designation.
- Registration Phase and Launch: Managed the MAA process, including dossier preparation, submission, and support during the evaluation process. Assisted with price and reimbursement (P&R) negotiations in Italy and supported product launch and maintenance activities.
Results
The client successfully obtained orphan drug designation, received valuable scientific advice, achieved marketing authorization, and effectively navigated the P&R landscape. The support provided by RPN enabled a smooth transition to product launch and ongoing maintenance in the market.