How-To & Explainers

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?  In this… 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

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

Need A WDA? Read Our Step By Step Guide

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

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

UK PSMF

The UK PSMF – What Will It Look Like?

How will the Pharmacovigilance System Master File (PSMF) be impacted by the UK’s departure from the EU?  What actions will… Read more

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple… Read more

MRP Grouped Variations

What You Need To Know About MRP Grouped Variations

Previously, we have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations… 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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