OUR EXPERTISE
Our experts in the quality, regulatory affairs and compliance fields support the largest healthcare stakeholders in their compliance with legislative, regulatory and administrative requirements.
Our Activities
- Audit
- Support
- Writing
- Documentation
- Submission & Declaration
- Operational support
- Training
- Outsourced functions
Our areas of expertise
- Quality Management System (QMS)
- Product quality
- Documents writing, variations, product information...
- Regulatory & product watch
- Personal data protection (GDPR)
- Anti benefits (DMOS)
- Transparency
News
- 20 April 2023
European Medicines Agency (EMA) strengthens PRIME (Priority Medicines) with new features
- 24 March 2023
The implementation of the European regulation on medical devices
- 13 March 2023
Forthcoming changes to accessing and managing EudraVigilance
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