Autologous cell product (cartilage defect)
The Project
Client was a small biotech company developing an autologous cell product for cartilage defects in need of development and regulatory support in a new and uncertain regulatory framework.
The Challenge
Development and regulatory support over 10 years needed for:
- Regulatory strategy
- CMC, nonclinical and clinical writing
- Paediatric Investigation Plan (PIP)
- eCTD preparation, submission
- Management of EU Centralized Procedure
- Preparations and conduct of Scientific Advices and Oral explanation
- Authorization Adaptations of Indication
The Solution
Implementation of dedicated senior project lead with extensive ATMP experience.
- Biopharma Excellence project leader as single point of contact for the customer:
- Program management
- Contact point for all questions
- Overall responsibility for all deliverables
- Coordination of all Biopharma Excellence experts
- Management of timelines and costs
- Dedicated ATMP team on the projects
- Proposed yearly budgets for specific services and work orders for various deliverables/services
The Outcome
Central Marketing Authorization achieved against all odds.
- Central Marketing Authorization for an ATMP
- Experts available with ATMP experience in regulatory, quality, nonclinical and clinical
- Access to know-how from many EMA submissions
- No need for implementation of an own state-of-the-art publishing tool
- Access to EU Health Authority opinion leaders via the extensive Biopharma Excellence network
- Flexible contractual framework allowing quick implementation of new work orders