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

International women's day

Every year on 8th March, International Women's Day is celebrated in many countries. This day, is dedicated to celebrating victories and achievements in women's rights and to reaffirming the importance of the struggle for wom (...)

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AxeRegel celebrates its 5th anniversary

Today we are celebrating AxeRegel’s 5th anniversary! Celebrate with us! AxeRegel is a regulatory affairs consultancy company focused on providing services in: Regulatory affairsQualityPharmacovigilanceMedical informationfor (...)

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Applying for orphan drug designation (ODD)

An orphan medicinal product is a medicine for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in 10,000 people in the European Uni (...)

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Pharmacovigilance local literature review: day zero

Marketing Authorisation Holders (MAHs) are required to monitor scientific and medical literature and to report individual cases of suspected adverse reactions for medicinal products, for which they hold a Marketing Authorisa (...)

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Happy New Year 2023!

AxeRegel's team wishes you a wonderful year 2023! We wish you happiness, health and serenity. And more, we wish you a 2023 filled with opportunities, possibilities and, above all, personal well-being and professional dynamis (...)

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Sanctions to pharmaceutical companies for shortage of medicines

The French National Agency for the Safety of Medicines and Health Products (ANSM) has updated on 08/08/2022 its guidelines for the determination of financial penalties in case of non-compliance of pharmaceutical companies with the regulation of medicinal products for which they are responsible:

  • New non-compliance cases subject to financial penalties are now listed in an Annex 3....

(Read more)

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 therapies for people living with rare diseases.

Rare Disease Day, the rarest day of the year, is organised every year on 28 February (or 29 in leap years). 

What is a rare disease? (Read more)

Role and duties of the Qualified Person (QP) in France

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 (...)

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

For more information about AxeRegel services, please contact us.

Recent posts:

21/09/2023: Let's Talk Big Data in Pharma: Transforming Healthcare together !

22/06/2023: Revision of the EU pharmaceutical legislation - the largest reform in over 20 years

21/03/2023: Medicine prices: is France still an attractive market?

08/03/2023: International Women's Rights Day 2023

28/02/2023: AxeRegel celebrates its 5th anniversary

24/02/2023: Applying for orphan drug designation (ODD)

10/02/2023: Guidelines on Good Manufacturing Practice for Investigational medicines

03/02/2023: CTIS use is now mandatory for new clinical trials in the EU/EEA

20/01/2023: Pharmacovigilance local literature review: day zero

02/01/2023: Happy New Year 2023!

30/12/2022: Have a wonderful holiday season!

21/12/2022: EudraVigilance user declaration for qualified persons for pharmacovigilance / responsible persons for EudraVigilance update

21/09/2022: Biosimilar medicines are interchangeable

15/09/2022: Qualified Person deputy in France

01/09/2022: How clinical trials are changing in Europe

23/08/2022: i-SPOC - Registration deadline coming soon!

11/08/2022: Sanctions to pharmaceutical companies for shortage of medicines

14/04/2022 : How to manage the impact of the war in Ukraine on clinical trials?

22/03/2022: European Good Pharmacovigilance Practices (GVP) on specific Risk Minimisation Measures of the pregnancy prevention program

15/03/2022: The iodine tablet rush

28/02/2022: Today is the rarest day of the year

17/02/2022: COVID-19: is green alert level imminent?

10/02/2022: Everybody can get a booster shot of COVID-19 vaccine

31/01/2022: New EU regulation on clinical trials of medicinal products: what is changing?

27/01/2021: Teleworking: how to stay in touch?

20/01/2022: Covid-19 vaccines: Where do we stand one year later?

06/01/2022: COVID-19: How to reconcile business continuity and worker protection?

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.