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

Start a conversation today


    We are now Cencora PharmaLex 

    PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. In 2024 and beyond PharmaLex and all the companies in PharmaLex family will begin a journey to becoming Cencora as well. Cencora brings the companies and services together under one new name. The name will change, but the level of attention and service you receive remains the same.  

    Know more