Advice & quality action plan

  • CGMP – FDA upgrade of production sites
  • Reorganization of the Quality structure in accordance with cGMP
  • ICHQ10 compliance of a Quality Management System
  • Quality Risk Management (ICHQ9), deviations, CAPA
  • Pre, post and inspection assistance
  • State of play, Product Quality Reviews, Institution Change Requests
  • Supplier’s specifications
  • Optimization of document systems, organization of archiving
  • Writing of procedures, operating modes, quality manuals
  • Design and implementation of internal trainer empowerment processes

Coaching & training

  • Coaching Personal Quality Coaching (QP, QP substitute , Operational or Functional Quality Assurance)
  • Other quality personal coaching (manufacturing, packaging, control laboratory, maintenance, supply chain, …)
  • Design and animation of GMP training modules on-demand (face-to-face, webinars, e-learning, …)
  • Assessment of achievements
  • Design of educational games, playful approach of GMP

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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