News & Insights

POST-MARKETING Surveillance

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised… 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

no deal Brexit Acorn Regulatory

Preparing for a No Deal Brexit – The 9th Acorn Regulatory Whitepaper

The seemingly never-ending Brexit negotiations have continued throughout the pandemic.  Talks initially held virtually, have now progressed to face to… 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

submission services ectd Acorn Regulatory

The 3 Options for eCTD Publishing & Submission Services

The transition from paper-based submissions to the more costly eCTD system has caused many companies to reconsider how they undertake… Read more

Rare Diseases Focus On Rare Orphan Drugs

Pharmacovigilance of Medicines for Rare Diseases

Dr. Danica Cvetkovic looks at the issue of pharmacovigilance for orphan or rare diseases.  Many issues associated with the sector… Read more

US FDA Electronic paper based dmf

The FDA Move from Paper to Electronic DMF’s

The transition from paper-based submissions to electronic Common Technical Document (eCTD) has continued in recent years.  This is something that… Read more

Brexit No Deal Guide

No-Deal Brexit Guide: Download it now

Covid-19 has focused the minds of politicians and the general public for the last 6 months.  During the pandemic, coverage… Read more

Veterinary Clinical Trials

Veterinary Clinical Trials: New EU Law & Global Approaches

Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given… Read more

medical devices regulatory affairs

Do You Want To Progress Your Medical Devices Career?

We are growing at a rapid pace at Acorn Regulatory.  Right now, we are seeking to hire a Senior Medical… Read more

UUID Numbers How To Fix

How To Fix Complications with UUID Numbers in eCTD

Acorn Regulatory’s publishing team is staffed by eCTD experts.  We have assisted many companies in their eCTD projects in recent… 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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