Featured News

Congratulations to Eileen Shortiss 10th Anniversary at Acorn Regulatory

Congratulations to Eileen Shortiss

This week marked the 10th anniversary of one of our senior and much valued Regulatory consultants.  Eileen Shortiss joined Acorn… Read more

Manufacturing Excellence Overview of EU Regulatory Framework - Acorn Regulatory Presents at Industry Event

Overview of EU Regulatory Framework – Acorn Regulatory Presents at Industry Event

In the first Manufacturing Excellence event of 2016 held by County Tipperary Chamber on 12th February, Dr. Gemma Robinson (Managing Director… Read more

Medical Literature Monitoring

Medical Literature Monitoring (MLM) – Current Status

The 1st September 2015 saw the rollout of the European Medicines Agency’s (EMA’s) much anticipated medical literature monitoring (MLM) service…. Read more

DMF Deadline

FDA Seeks Input on New Technology for Conducting Clinical Trials

Last October saw the publication of a request for comments from the FDA on new technologies and methods for conducting… Read more

Periodic Safety Update Single Assessment

Periodic Safety Update Single Assessment (PSUSA) – An Overview

In this blog, we look at the Periodic Safety Update Single Assessment or PSUSA.

GVP Pharmacovigilance and social media - Acorn Regulatory

2015: Good Pharmacovigilance Practice (GvP) and Social Media

Editor’s Note:  This article about GvP and social media is one of the most read articles ever on our website. … Read more

CE Marking A Medical Device

CE Marking a Medical Device

CE marking a medical device and placing it on the market in the EU requires several steps that need to… Read more

In Vitro Diagnostic Medical Device Regulations Acorn Regulatory

Update on the new EU In Vitro Diagnostic Medical Device Regulation: Seven Key Changes

Editor’s note:  This post was first published in November 2015.  Since then we have written extensively on the issue of… Read more

acorn

EDMA Publishes a Position Paper on New EU IVD Regulation

In 2012, the European Commission proposed draft text for a new EU IVD regulation to replace the IVD directive 98/79/EC…. 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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