ATMPs Quality Assurance
The MEARY Center has an ATMPs Quality Management System Department.
With considerable expertise in Cell Therapy and ATMPs, as well as mastery of the pharmaceutical quality system, 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)