Descriptif : AxeRegel est une société de conseil en affaires réglementaires, pharmaceutiques et pharmacovigilance fondée sur la volonté d’apporter une plus-value aux entreprises du domaine de la santé. Nos services vont de l (...)

Le Pharmacien Responsable (PR) un élément clé des entreprises pharmaceutiques françaises Le Pharmacien Responsable en France dispose d’une place privilégiée au sein de la direction de l'entreprise pharmaceutique. Il cumule d (...)

Le 25 mai 2018 le règlement européen relatif à la protection des personnes physiques à l'égard du traitement des données à caractère personnel et à la libre circulation de ces données (RGPD) entrera en vigueur. Il sera appli (...)

Every year, the European Medicines Agency (EMA) adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year.On 1 April 2018 general, non-pharmacovigilance fees payable to EMA by app (...)

Regulation (EU) 2016/679, the European Union’s (EU) new General Data Protection Regulation regulates the processing by an individual, a company or an organisation of personal data relating to individuals in the EU. This regu (...)

AxeRegel is a regulatory and pharmaceutical affairs consultancy company based in France. We offer regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products.With (...)

The European Medicines Agency (EMA) will be closed from 18:30 on Tuesday 8 May until 7:30 on Monday 14 May 2018.EMA

Melatonin is an hormone secreted naturally during the night. Among other things, melatonin promotes sleep, modules mood and the immune system, regulates the body temperature and the intestinal motricity.In France, melatonin (...)

On February 5, 2018 the French National Security Agency for Medicines and Health Products (ANSM) published an updated version of its Good Pharmacovigilance Practices (GVP). France GVP were first published on 2005 and then up (...)