Axelys Santé > Regulatory and Pharmaceutical Affairs
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