The January 2019 Newsletter from Acorn Regulatory
Is it too late to wish you a Happy New Year? We hope not. Welcome to the January 2019 of our monthly newsletter. This year is going to be an interesting year with so much happening that will impact on...
RMS In the UK? Here Is What You Need To Do
Reference Member States (RMS) have rarely been changed, as there has been no need to do so. Brexit has changed all of that and now many companies are having to change their RMS because of the UK’s decision to leave...
Articles from the Archive – In Case You Missed It
Our expert team has written over 300 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 third edition of #ICYMI (In Case You Missed...
Will The Updated CMC Guidelines Impact On Your Business?
Our overview will assist you in understanding the impact that the 2018 amendments will have on CMC guidelines. The updated CMC guidelines on the manufacture of the finished dosage form, CHMP/QWP/486/95, first issued in April 1996, were updated and the...
Acorn Regulatory July 2018 Newsletter
Hello and welcome to our July 2018 newsletter. As Ireland has basked in an almost unprecedented heatwave, we have been busy with numerous projects for our clients around the world. We have also refreshed our brand and launched a new...
What Are The Common Mistakes With CEP’s?
The Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph...
Uncertainty Abounds – How Customs Issues Are Now Dominating Brexit
There has been much spoken and written about Brexit since our last whitepaper, yet very little has progressed. The issue dogging the talks, that of the Irish border, has caused negotiations to move much like a tortoise when the pace...
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.
