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Latest News

Right now, we are seeking to recruit a Project Manager with regulatory experience to join us on a contract basis (9 months).  

New Vacancy for 2020: Pharmacy Graduate

We are actively recruiting for a pharmacy graduate to join our growing pharmacovigilance team.

MDD to MDR white

Moving from MDD to MDR? Here Is What You Need To Know

MDR will come in to force in 2021.  It differs greatly from the MDD.  What will the major changes be… Read more

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about… Read more

Clinical Evaluation Reports

How To Write An Effective CER

The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the… Read more

Update on the EU Authorised Representative & Brexit

The UK is no longer a member of the European Union. However, until December 31st, 2020 it will be bound… Read more

Guidance for MAHs Covid 19

Expectations for Human Use Products During The Covid-19 Pandemic

The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency… Read more

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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