28/02/2023
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 the pharm
23/02/2023
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
10/02/2023
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 ensu
03/02/2023
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
20/01/2023
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 i