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

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

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

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

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