QMS & Regulatory Affairs
As a health care startup, the quality of our data and results depends on an efficient Quality Management System in compliance with the guidelines and standards relevant to our activities.
The commitment of the Executive Committee and our Quality Policy guide our activities according to 3 axes:
- Ensure a high level of quality on our processes, products and services for the safety of the patient. This is achieved by implementing a continuous improvement system.
- Involve the entire company in our objectives, costs and deadlines by making individuals responsible for their activities and projects.
- Set up a management system allowing the cohesion of the teams by the definition of common values.
Our status as a pharmaceutical establishment authorized and inspected by the ANSM (GMP certificate below), allows us to manufacture and certify an Advanced Therapy Medicinal Product resulting from tissue engineering.
This ATMP has been tested in a Phase I/IIb clinical trial and will be tested in a Phase III study. The design and development of our cell culture and expansion platform is recognized by the British Standards Institution through our ISO 13485: 2016 certification (see below).
