Quality evaluation

Process quality

  • Risk analysis for the management of suppliers and subcontractors
  • Optimization of processes and product flows
  • Harmonization of multi-site practices
  • Qualification of the equipment: from the elaboration of the protocol to the writing of the qualification report
  • Setting up Lean management

Medical devices

  • Support for the implementation of the quality system according to ISO 13485 standard
  • Preparation of the certification audit by the notified body and inspections by competent authorities

Qualification and validation

  • Policy development and validation strategy
  • Design and realization of criticality analyzes
  • Document architecture and validation
  • Writing of all validation documents
  • Supervision of tests, management of nonconformities


  • Audits of API suppliers and pharmaceutical excipients
  • Distributor audits
  • Audits of pharmaceutical sub-contractors
  • Suppliers of raw materials:
    – validation of the Quality Control system
    – audit of quality systems
  • Shared audits
  • Audit of suppliers of cosmetic excipients
  • Evaluation of cosmetic GMP processes

    We support you throughout all steps of the conception and lifecycle of your products ensuring a complete quality service.

    Thanks to our participation to international networks Regulanet and Pharmaxi, we have a privileged access to specialists in more than 90 countries.

    53, Boulevard de la Reine
    78000 Versailles - France
    Tél : +33 (0)1 42 86 86 00

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