NEWS AND EVENTS

Over the past decade, supply chains within the pharmaceutical industry have become increasingly comp...

The presence of nitrosamine impurities in medicinal products has raised safety concerns regarding th...

EudraVigilance is the European data-processing network and database management system for the exchan...

The integration of Artificial Intelligence (AI) into medical devices is revolutionizing healthcare, ...

Billev Pharma East experts can act as your outsourced PRRC, helping your Company comply with EU regu...

At the end of January 2024 Swissmedic updated its Q&A document Update of the requirements for de...

In order to combat critical medicines shortages The European Medicines Agency (EMA) together with th...

Billev Pharma East is proud to announce that we have become a member of the elite SBC club of the mo...

The regulation of a combination products (the combination of a medicinal product and a medical devic...

On December 2023 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnost...

The Medicines and Healthcare products Regulatory Agency (MHRA) signed a Grant Agreement with the Con...

In December 2023, Medical Device Coordination Group (MDCG) issued a revised document, MDCG 2021-27 R...

EMA, the European Commission, and the Heads of Medicines Agencies (HMA) have phased out the special ...

Regulation (EU) 2017/745 – also known as the Medical Devices Regulation (MDR) was adopted on May 2...

Europe's healthcare systems confront formidable challenges, imperilling access, affordability, and q...

The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence durin...