AxeRegel

Let’s dive into something that's reshaping the landscape of the pharmaceutical industry: Big Data. Big Data isn't just a trend; it's a revolution. Imagine vast amounts of data from clinical trials, patient records, genomics, (...)

On 26 April 2023, the European Commission presented its project to revise the EU's pharmaceutical legislation. This revision, which is part of the Pharmaceutical Strategy for Europe presented by the European Commission in No (...)

In the European Union, decisions on pricing and reimbursement of medicinal products are made at a national level following negotiations between governments and Marketing Authorisation Holders (MAH).  In France, after obtaini (...)

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 (...)

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 (...)

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 (...)

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 whi (...)

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 (...)

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 (...)

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 (...)