Regulatory Strategy

Focus on Variations

Acorn Regulatory’s pharmaceutical regulatory affairs consultants are experts in the sector.  Every day our team members are working on behalf… Read more

Brexit information from Acorn Regulatory

Brexit Information for Life Science Companies – June 2018 Edition

The Brexit project is  ever changing and keeping up to date with how it impacts on the life sciences sector… Read more

baseline submissions Acorn Regulatory

Baseline Submissions & The January 1st NeeS Deadline

We have written extensively on issues relating to electronic publishing of submissions.  In fact, Acorn Regulatory was one of the… Read more

Marketing Authorisations

Marketing Authorisation Holders – An Overview

Acorn Regulatory’s consultants are experts in the sector.    Members of our pharmaceutical regulatory affairs team have written extensively on… Read more

Can Improvements Be Made To The Readability of Package Leaflets?

We look at the possible changes that could be made to package leaflets to improve their comprehension and readability.

Guidelines For Notification of Serious Breaches of Regulation (EU) No. 536/2014

Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious… Read more

Well established use

Is Well Established Use Going Out of Fashion?

The choice of legal basis is one of the most crucial choices that a Marketing Authorisation Holder must make.  One… Read more

Brexit Information for the Pharmaceutical Sector

In this blog we look at a number of Brexit information resources for the pharmaceutical sector. 

Life Science Sector Deal

Blog: The UK Life Science Strategy Sector Deal & The Role of Regulatory Affairs

While the UK government may not have carried out sectoral analysis of the impact of Brexit, it has developed a… 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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