QUALITY ASSURANCE

  • Implementation or evolution Quality Management System (GMP & annexes, GDP)
    • “Exploitant” and production sites
    • R&D (clinical batches supply)
  • Internal or external audits (CMO, CDMO)
  • Preparation and implementation of regulatory inspections

Achievements


  •  QMS implementation and evolution in  pharmaceutical development (clinical trial material).
  • Preparation, monitoring and management of Health Authorities or partners inspections