Quality and regulatory affairs

Efficient quality assurance and effective regulatory watch for optimum oversight.

Quality assurance system and certifications

Quality assurance system and certifications

Recognized as FRANCE’S LARGEST 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 NF S 96-900 certification
  • Application of good pharmaceutical practices: GMP, GCP, GCLP and GDP
  • 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
Regulatory procedures

Regulatory procedures

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

  • CODECOH: registered with the French Ministry for Research to prepare and store human biosamples for our client’s research programs
  • 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.

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