Quality and regulatory affairs

Recognized as FRANCE’S LARGEST PRIVATE BIOBANK, our goal is to deliver the highest quality of sample management by applying quality systems adapted or dedicated to our activities.

• ISO 9001 and ISO 20387 certification
• Application of good pharmaceutical practices: GMP, GCP, GCLP and GDP
• Authorization and GMP certification by the French Agency for the Safety of Medicine and Health Products (ANSM) to store pharmaceutical starting materials (drug substances and excipients…)
• Authorization by the ANSM to store cell therapy and tissue banks
• Compliance with BPR (Best Practices for Repositories, ISBER)
• Qualification of cold storage units in accordance with the FD X15-140 standard
• Software validation in accordance with EU GMP Annex 11 and FDA 21 CFR Part 11

Cell&Co notably holds the following regulatory authorizations applicable to its current activities:

• Possibility of submitting import/export authorization requests to the MESRI (French Ministry of Higher Education, Research and Innovation), as part of a research/scientific program, for which Cell&Co is a storage site, exclusively on behalf of foreign customers.
• ANSM authorization to distribute and import pharmaceutical raw materials

Cell&Co conducts regulatory watch in order to anticipate any developments that may impact its business or clients

Before the launch of each project, Cell&Co carries out the administrative formalities relating to the operational activities and samples entrusted to it by the client, and in particular:

• Import authorization
• Export authorization
• Declaration of use of regulated biological materials.

These formalities and procedures are conducted with all competent authorities, whether in France or abroad.