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