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
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.