We have the knowledge and expertise to enable you deal with the constant changes in health products regulation and achieve your company’s strategic objectives. Our tailor-made support adapts to your needs, in your regulatory processes, throughout your products life cycle.
We carry out the following missions :
- Advice and implementation of registration strategies for your health products
- Interaction with health authorities, consultation meetings, request for scientific advice
- European and International regulatory and competitive intelligence on health products
- Assessing the impact of new regulations and legislation
- Preparation and submission of regulatory and scientific applications to health authorities. Requests for clinical trial authorizations, temporary recommendations for use or request for imports, export files, etc.
- Monitoring of pharmacovigilance activities: report writing, management of additional information requests and follow-up of risk management plans (RMP)
- Review and validation of promotional materials and health claims
- Filing and follow-up of advertising visa applications with the competent authorities