Regulatory Affairs

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 post-Br

Pharmaceutical serialization: the final countdown

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

EMA new fees

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

AxeRegel Regulatory consulting

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