How-To & Explainers

Acorn Regulatory Repeat Use Procedure Slide Deck

Download Our Repeat Use Procedure Slide Deck

The issue of Repeat Use Procedures generates many questions to our pharmaceutical regulatory affairs team.  We have created a slide… Read more

Regulatory Intelligence 9

Download ‘Regulatory Intelligence 9’ from Acorn Regulatory

‘Regulatory Intelligence 9’ from Acorn Regulatory has a wide range of articles covering issues such as Brexit, the new Medical… Read more

Unique device identifier Acorn Regulatory explains

What Is A Unique Device Identifier?

The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on… Read more

GUIDE TO IMPROVING PACKAGE LEAFLET READABILITY

How To Improve The Readability of Package Leaflets

What changes could be made to the readability of package leaflets to make them more accessible for patients?  Eileen Shortiss,… Read more

eCTD validation issues the latest article from Acorn Regulatory

How To Fix Common eCTD Validation Issues

Previously, we looked at issues that arise within eCTD.  Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in… Read more

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

MRP Grouped Variations

What You Need To Know About MRP Grouped Variations

We have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations with… 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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