AxeRegel
Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products
Welcome to AxeRegel
AxeRegel is a regulatory and pharmaceutical affairs consultancy company based in France. With a wide experience in the field, we provide individually tailored, high quality and flexible solutions in the areas of medicines, medical devices, cosmetic products and food supplements.
AxeRegel regulatory, pharmaceutical and pharmacovigilance services
Regulatory Affairs comprise several activities that go from the submission of a Marketing Authorisation application of a medicine to it's Post-approval lifecycle maintenance, passing through the validation of packaging material and of Product Information.
We are at your side to help you find the solution to your needs.
Do you need to delegate part of your vigilance obligations or do you need a ponctuel support for a specific activity?
We offer you a scientific expertise adapted to your needs and projects.
The "exploitant" is a status applied in France to companies performing commercial activities related with medicinal products.
We can provide you permanent or temporary support in the performance of your exploitant activities.
AxeRegel regulatory ressources
Medicinal products
Are substances used to treat or prevent disease in human beings, or used to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis.
Learn about medicines regulation.
Cosmetic products
Are products intended to cleanse, perfume, change the appearance, protect or keep a person in good condition or correct body odours.
Learn about Cosmetics regulation.
Food supplements
Are foodstuffs intended to supplement the normal diet which are concentrated source of nutrients with a nutritional or physiological effect, alone or in combination, marketed in “dose” form.
Learn about food supplements regulation.
Medical devices
Is an article, instrument, software or machine intended to be used for human beings in the prevention, diagnosis or treatment of illness or disease or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for health purpose. Its principal intended action is not achieved by pharmacological, immunological or metabolic means.
Learn about medical devices regulation.