Acorn Regulatory’s Top 100 Articles

Understanding MDR The Role of the PRRC Responsible Person

PRRC: The 5 Responsibilities of the Person Responsible for Regulatory Compliance under MDR

This article is part of our series of MDR articles that look at the changes coming into play with the… Read more

PSUSA Deadline How To Guide

How To Prepare For A PSUSA Deadline

Do you have a PSUR Single Assessment (PSUSA) submission deadline approaching?  If so, our Regulatory Publishing Manager, Eileen Ryan, has… Read more

Medicinal Product Labelling: What You Need To Know

Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to… Read more

Moving EU Authorised Representative: Find Out How To Move

Does your company currently have an EU Authorised Representative that is based in the United Kingdom?  If so, your company… Read more

Steps to CE Marking an IVD Medical Device

Steps to CE Marking an IVD Medical Device

One of the most frequent questions we are asked is: how do you CE mark an IVD device?  We will… Read more

EU Based QPPV October 17th 2019

EU Based QPPV – Is Your Company Ready for Brexit?

As Brexit negotiations reach their most critical point, it looks today (October 17th, 2019) that a deal is in sight. … Read more

Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We… Read more

Pharmacovigilance Inspection Acorn Regulatory

Updated: How To Prepare For A Pharmacovigilance Inspection

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to… Read more

Post Authorisation Safety Studies - Acorn Regulatory

What Are Post Authorisation Safety Studies? 

Post authorisation safety studies (PASS) are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine… 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.
©2020 Acorn Regulatory Consultancy Services Ltd. Company Registration No. 397294 VAT Registered No. IE 6417294V
Designed by