Documented Information Procedures – What You Need To Know Ahead of The Deadline
ISO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that have not yet upgraded to the revised standard, the ISO 9001:2008 certification expiry date will soon be approaching. Control of...
#ICYMI – In Case You Missed It – Featured Articles from the Archive
Our expert team has written over 500 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this first edition of #ICYMI we are featuring articles...
Brexit Information for Life Science Companies – June 2018 Edition
The Brexit project is ever changing and keeping up to date with how it impacts on the life sciences sector is a difficult task. Here, we have highlighted some Brexit information for life science companies and we assess its impact.
Virtual Wholesaling of Medicinal Products: 5 Things You Need To Know
What is virtual wholesaling? It is a topic that we get asked about time and again. So, we have produced a quick to read guide detailing 5 things that you need to know about the topic.
Baseline Submissions & The January 1st NeeS Deadline
We have written extensively on issues relating to electronic publishing of submissions. In fact, Acorn Regulatory was one of the very first companies to embark on electronic publishing on behalf of client companies many years ago. As the eSubmission Roadmap...
Acorn Regulatory May 2018 Newsletter
Hello and welcome to the May edition of the Acorn Regulatory newsletter. Regular readers of the newsletter will have noticed that our company has been growing. In recent months we have welcomed several new members to our team. This month...
Marketing Authorisation Holders – An Overview
Acorn Regulatory’s consultants are experts in the sector. Members of our pharmaceutical regulatory affairs team have written extensively on this website and in other industry publications about the issues associated with marketing authorisation holders and much more. Below, we...
Orphan Drugs: 10 Facts You Need To Know
Much has been written about orphan drugs in recent times. These products, developed specifically to treat a rare disease, have become more common in the marketplace. At the time of writing (May 2018) there are almost 300 orphan drugs commercially...
Acorn Regulatory Takes Part in Enterprise Ireland & IDA 2018 Trade Mission Events
Acorn Regulatory staff took part in a number of the Enterprise Ireland & IDA Trade Mission events in Dublin and Sligo recently. The purpose of the trade missions was to facilitate networking opportunities between Enterprise Ireland clients (of which Acorn Regulatory is...
The Worksharing Procedure for Variations for National Marketing Authorisations in the EU
Did you know that Article 20 of Commission Regulation, known as the ‘Variations Regulation, allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one...
