Quality System and Audit

Our experienced consultants can assist in designing and implementing a quality system that meets regulatory expectations in France.  

 

Our services in this area include:

  • Advice & operational support for pharmaceutical companies located in France for a quality system that meets regulatory expectations for an “Exploitant” status
  • Provision of deputy “Exploitant” QPs (PRI)
  • Risk analysis / Process mapping
  • Advice, review or preparation of:
    • Product Quality reviews (PQR)
    • Client-customized SOPs or quality manuals,
    • Quality technical agreements
    • Application for obtaining the “Exploitant” status from ANSM and annual reports
    • Contingency plans for drug shortage (PGP) for medicinal products of major therapeutic interest (MITM)
    • Serialization
  • Audits of pharmaceutical processes according to GMP, GDP or “Exploitant” activities
  • Preparation and support prior to ANSM inspection
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