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 Blog

New post: France prohibits the use of titanium dioxide in foodstuffs

On 25th April 2019 the French Government has made use of the precautionary principle by prohibiting from 1 January 2020 the placing on the market of foodstuffs (including food supplements) containing the additive E171 (titanium dioxide - TiO2).

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What is an exploitant pharmaceutical site?

The "exploitant" is a status applied in France to companies performing commercial activities related with medical products. These activities include the wholesale and distribution free of charge of medicines, advertising, information, pharmacovigilance, batch follow-up, and if required, batch recall operations, as well as the corresponding storage activities.

AxeRegel has participated on 17 June 2018 in the running tour that took place in the splendid gardens of Château de Versailles and made a Royal performance.

Published on LinkedIn on 07/05/2018: An online presence is very important nowadays, that is the reason why we are celebrating this week our Go online.

The Qualified Person (QP) a key function in the French pharmaceutical companies 

The Qualified Person is a privileged function in France. Placed at the heart of the board of directors of the French pharmaceutical companies, the QP accumulates several responsabilités and is the privileged interlocutor of the Health authorities. The Qualified Person is the guarantor of the respect of the French Health Code (CSP) inside the pharmaceutical company, and more generally, of medicines' safety.

GDPR/GRPD General Data Protection Regulation implemented on May 2018

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 regulation harmonizes data privacy laws across Europe and is enforced since 25 May 2018.

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EMA new fees

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 (...)

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AxeRegel Regulatory consulting

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 (...)

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France updates its GVPs / BPFs

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 (...)

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