ATMPs Quality Assurance
The MEARY Center has an ATMPs Quality Management System Department headed by Dr. Hélène Boucher-Pillet.
With considerable expertise in Cell Therapy and ATMPs, as well as mastery of the pharmaceutical quality system, Dr Boucher-Pillet's team offers a range of specialized skills at your service.
Expertises & Services
- Assistance in the drafting of technical-regulatory dossiers for ATMPs
- Setting up clinical trials for experimental ATMPs and their technical and regulatory management
- Management of a Pharmaceutical Quality System
- Good Manufacturing Practices, part IV
- Audits (internal and external)
Autorisations
- GMO approval n°5691 (Ministry of Higher Education, Research and Innovation)
- Authorisation ANSM TIE/19/O/001 (Eudra GMP)