ATMPs Quality Assurance
The MEARY Center has a Quality Assurance Department with recognized expertise in pharmaceutical quality, specifically adapted to cell therapies and advanced therapy medicinal products (ATMPs).
Expertises & Services
- Support in drafting regulatory files for experimental ATMPs
- Managing a pharmaceutical quality system
- Compliance with Good Manufacturing Practices (GMP)
- Internal and external audits
Approvals
- Installation approval L2-1491 for use of genetically modified organisms in contained systems
- ANSM authorization TIE/19/O/001 (Eudra GMP)