Quality & Regulatory

We are committed to provide you with experts who have a deep knowledge of regulatory requirements on different markets. We are able to support you from regulatory guidelines interpretation to the operational implementation of worldwide regulatory guidelines

Area of expertise :

  • Regulatory strategy
  • Stakeholder management : health autority, regulatory subsidiary, manufacturing site, etc.
  • Submission support
  • Advertising monitoring
  • Update of regulatory databases
  • Regulatory Intelligence : develop and strenghten regulatory policy within your company
  • Document management for regulatory agencies (FDA, the EMA …)
  • Quality control and quality assurance
  • Validation & qualification
  • Deviation & CAPA