Pharmaceutical

Drug Device Combination Products Acorn Regulatory

Drug Device Combination Products: An Acorn Regulatory Overview

The European medical devices regulation (MDR) 2017/745/EC was published on 5th May 2017 and has updated significantly the requirements for… Read more

Guidance for MAHs Covid 19

Expectations for Human Use Products During The Covid-19 Pandemic

The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency… Read more

 COVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work.

The Competent Authorities Response to Covid-19

COVID-19 has transformed almost every aspect of our daily lives. Nevertheless,  patient safety must remain a priority. COVID-19 may force MAHs… Read more

orphan drug Acorn Regulatory

Updated for 2020: Development of the Orphan Drug Sector

The orphan drug pipeline continues to grow and the sector has attracted considerable interest.  We have updated this article for… Read more

Regulatory Intelligence 8

Download ‘Regulatory Intelligence 8’

Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. … 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

Most Read Pharmacovigilance & Medical Articles of 2019

Our pharmacovigilance and medical teams have had a busy 2019.  During the course of the year they have taken the… Read more

eCTD Electronic Publishing Acorn Regulatory

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage… 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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