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

Brexit Impact: Updates on QRD Templates!

Updates from the European Medicines Agency (EMA) shed light on the recent revision of the QRD Templates, particularly tailored to comply with QRD template v10.4 updated on 29/02/2024, addressing the regulatory implications p (...)

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Happy New Year 2024!

Happy New Year 2024!  As we step into this bright new year, all of us at AxeRegel extend our warmest wishes to our valued partners, clients, and the entire healthcare community. 2023 was a remarkable year, filled with challe (...)

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Medicines Under Additional Monitoring

In the dynamic world of pharmaceuticals, it's imperative for pharmaceutical companies to remain informed about new developments that prioritize patient safety and promote responsible medication use. Today, we're shedding lig (...)

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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 women's rights and gender equality.

International Women's Day, established in 1977 by the United Nations (UN). ....

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 Union) or where the medicine is unlikely to generate sufficient profit to justify research and development costs. 

About 30 million people living in the European Union (EU) suffer from a rare disease.

Orphan designation can only be granted in the EU, by the European Commission

CTIS use is now mandatory for new clinical trials in the EU/EEA

The new Clinical Trials Regulation (Regulation (EU) No 536/2014) entered into application on 31 January 2022, repealing the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States.

The Clinical Trials Regulation (CTR) harmonizes and streamlines the submission, assessment and supervision processes for clinical trials in the EU through the Clinical Trials Information System (CTIS)...

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....

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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 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 (...)

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 Authorisation in the EEA.

The literature review includes literature on the benefit/risk profile of the product and not just individual cases of suspected adverse reactions (also referred to as individual case safety reports (ICSRs)). It should also identify any emerging safety issues (ESI)...

Guidelines on Good Manufacturing Practice for Investigational medicines

In clinical trials there may be added risk to the subjects compared to patients treated with authorised medicinal products.

Investigational medicinal products are therefore manufactured by applying manufacturing practice which ensures the quality of such medicinal products in order to safeguard the safety of the subject and the reliability and robustness of clinical data generated in the clinical trial (article 63, paragraph 1, Regulation (EU) n° 536/2014)....

For more information about AxeRegel services, please contact us.

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

Recent posts:

28/05/2024: Navigating the Intersection of Medicines and Medical Devices

16/05/2024: Stay Compliant with the Latest EudraVigilance Updates!

14/03/2024: Brexit Impact: Updates on QRD Templates!

21/01/2024: EMA's Latest Guidance on Electronic Submission of Information for Investigational Medicinal Products in XEVMPD

17/01/2024: Happy New Year 2024!

01/11/2023: Medicines Under Additional Monitoring

18/10/2023: Exciting Updates in the European Medicines Agency Post-Authorisation Procedural Advice for users of the centralised procedure!

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.