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.
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.
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.