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

GMP, GCP and IRIS guides

The guide for applicants and Marketing Authorization Holders (MAH) involved in GMP and GCP inspections coordinated by the EMA as well as the IRIS guide have been updated. Good Manufacturing Practices (GMP) are the principles (...)

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The iodine tablet rush

Taking iodine tablets as a precaution against the nuclear threat is unnecessary and dangerous. After the bombing of the Ukrainian nuclear plant in Zaporizhia on 4 March (six of Ukraine's 15 nuclear reactors are located in th (...)

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Today is the rarest day of the year

Since its creation in 2008, Rare Disease Day has played a key role in building an international rare disease community working towards equality in terms of social opportunities, healthcare and access to diagnosis and therapi (...)

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COVID-19: is green alert level imminent?

For a few weeks now we have been seeing an improvement in the epidemic situation of COVID-19. We almost didn't dare to believe it, even if deep down we all want things to change once and for all and not just a bit. Well, for (...)

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Teleworking: how to stay in touch?

We all know that teleworking "contributes to the prevention of the risk of SARS-CoV-2 infection and makes it possible to limit social interactions in the areas surrounding the workplace and on the way to and from work&q (...)

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Happy New Year 2022!

The AxeRegel team wishes you all the best for the year 2022. We wish you a new year filled with joy, happiness, success and health.

It is with many exciting projects that AxeRegel begins this year and we hope to live them with you.

We would like to take this opportunity to thank you sincerely for your continued commitment throughout this complicated year due to the Covid-19 health context.

A warm thank you!

Sara Fonseca

President

Telephone: 01 72 69 01 81

E-mail: contact@axeregel.com

Website: www.axeregel.com

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

For more information about AxeRegel services, please contact us.

Recent posts:

Vigilance services

Do you need to delegate part of your vigilance obligations or do you need a temporary support for a specific activity?

We can offer you a scientific expertise adapted to your needs and projects.

We love sport

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.

Go online

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.

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.