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 website.  You can read more about that change in the July newsletter. Also, as ever, our expert staff have produced a number of articles this month that will be of interest to regulatory professionals.

As ever, we welcome your feedback to

New Website

We are delighted to launch our new updated website.  The site, as ever, is packed with hundreds of pages of informative articles about issues relating to regulatory affairs, pharmacovigilance, quality, clinical and much more.  It also gives a comprehensive briefing on the diverse range of services that we offer. Take a look for yourself here.

Download Our 6th Brexit Whitepaper  

The course of Brexit has been filled with dramatic twists and unexpected happenings. How will the Brexit drama impact on life science companies and, importantly, is time running out? Find out more in our latest Brexit whitepaper. Download your free e-book here.

Baseline Submissions and the January 1st Deadline

As the eSubmission Roadmap continues apace we are now looking to the next deadline of January 1st 2019 when all regulatory activities in National Procedures (NP) will need to be completed in eCTD.  NeeS submissions will not be accepted in any European Union member state after December 31st 2018 and, as a result, companies not already submitting in eCTD need to start considering their next steps. Read the article here.

Welcome Back to Eileen Ryan

Long time clients of our company will know Eileen Ryan and we are delighted to welcome her back to the company.  Eileen rejoins as Manager of our electronic publishing team.

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 documents is an intrinsic element of ISO 9001: 2015 and with the transitional period set to end you should be aware of the need to maintain and retain. We explain how you can best manage documented information in this article. Read more here.

In Case You Missed It – Articles from the Acorn Regulatory Archive

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 second edition of #ICYMI (In Case You Missed It) we are featuring articles on issues as diverse as DCP Close Out’s, medicinal product labelling, this year’s hot topic of GDPR and pharmacovigilance KPI’s. Read more from the Acorn Regulatory archives here.

Find Out More About Our Services For Medical Device Companies

Our medical device team works with a wide range of companies to assist them on a range of issues.  Right now, we are working on a diverse range of projects and we can assist your company on any issues related to medial devices.  Find out more about our services here.

Download Our New Brochure

Our new company brochure is available to read and download here.The brochure looks at the wide range of services offered by Acorn Regulatory to companies around the world.

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