Conseil et coaching
STRATEGIC ANALYZES

  • Definition of development and registration strategies based on product specificities and regulatory requirements
  • Definition of the non-clinical and clinical regulatory strategy: evaluation of the program and clinical protocols (with our partner Heathics)
  • Decision support before acquiring products or records
  • Audit of pharmaceutical, toxicological and clinical records
  • Online support: answers to your questions in real time on all topics related to pharmaceutical development and regulatory affairs

ADVICE & QUALITY ACTION PLAN

With our partner

  • 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

With our partner

  • 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

STRATÉGIE SANTÉ
19, rue Georges Clemenceau
78000 Versailles - France
Tél. +33 (0)1 42 86 86 00
contact@strategiesante.com