News & Events
ANSM – FDA
GMP certificate renewal and successful FDA inspection
Quality and regulatory compliance are the pillars of Clean Cells in order to meet the needs of our customers and support them in the successful development of their biological products.
GMP certificate renewal
Following the transfer of our activities at the beginning of this year to our new state-of-the-art facility, we have been inspected in April 2023 by the French regulatory authority, ANSM (Agence nationale de sécurité du medicament et des produits de santé).
As an outcome to this inspection, our GMP certificate has been granted to our new site, providing regulatory confirmation of the successful start-up of this site in few months.
Certificates are available upon request.
Successful FDA inspection
As part of our continued international growth and the quality control of marketed products, we hosted a Pre-Approval Inspection (PAI) from the FDA (Food and Drug Administration) focused on a bioassay carried out on commercial products. No 483 form was issued at the end of the inspection, confirming the strength of our quality system and our technical experience.
It demonstrates that, in addition to our scientific expertise and our wide range of services, our quality system and the procedures in place meet global regulatory requirements.
This inspection track record comes on top of more than a dozen customer audits since the beginning of this year. Their positive feedback supports the fact that Clean Cells is a key partner for companies developing innovative biological medicines.
Feel free to contact us to discuss the best solutions for the successful development of your biological products.