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 post-Br

Falsified medicines may contain ingredients of bad or toxic quality, or in the wrong ingredient or the wrong dosage. They represent a serious risk to public health that is the reason why the European Union (EU) put in place a comp

Every year, the European Medicines Agency (EMA) adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year.On 1 April 2018 general, non-pharmacovigilance fees payable to E

Regulation (EU) 2016/679, the European Union’s (EU) new General Data Protection Regulation regulates the processing by an individual, a company or an organisation of personal data relating to individuals in the EU. This regulation

AxeRegel is a regulatory and pharmaceutical affairs consultancy company based in France. We offer regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products.W