The Acorn Regulatory Brexit Guide No. 1 Revised for 2020
We published our first Brexit guide in July 2016. Back then, we looked at the potential implications for the life sciences sector. Now, we know much more about how Brexit will look at the moves that companies need to take...
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How To Improve The Readability of Package Leaflets
What changes could be made to the readability of package leaflets to make them more accessible for patients? Eileen Shortiss, a Senior Regulatory Affairs Advisor at Acorn Regulatory is our in-house expert on all matters relating to package information leaflets. ...
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 clients. A number of clients have asked us to write about the issue. Here, we have outlined an overview on...
Most Read Pharmaceutical Articles of 2019
Our expert team has written hundreds of well received and widely shared articles in recent years. This year, they wrote over one hundred expert articles on a wide range of subjects. below, we have featured some of the most read...
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KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application
What is KASA and how will it impact on getting a drug assessed by the US FDA? We look at its ‘3 pillars’ and what it aims to be. Importantly, we look at how the FDA believes it will change...
Applying For A WDA? Follow These 5 Steps
The issue of Wholesale Distribution Authorisations has been a hot topic for companies for many years. We work with a large number of companies who utilise our Responsible Person and WDA services. In this article, we look at 5 steps...
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‘Selected Writing from Acorn Regulatory’ Download It Here
‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the past 12 months. This e-book is packed with regulatory and pharmacovigilance insights from the team at Acorn Regulatory. Download it...
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Can You Use A U.S. Dossier To Apply For A European Marketing Authorisation?
Is it possible to use a U.S. dossier when applying for an E.U. marketing authorisation? This is a question that is asked time and again. We first published this article in 2017. We have updated it and included links to...
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UPDATED: What Are The Initial Steps in Applying for a Marketing Authorisation?
We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA). In this article we aim to provide a guide to assist companies applying for an MA We have also provided a number of links throughout...
Your eCTD Questions Answered
Acorn Regulatory’s publishing team is staffed by eCTD experts. We have assisted many companies in their eCTD projects in recent years. Many visitors to our website submit questions on regulatory issues. In this blog post, Eileen Ryan, our Regulatory Publishing...
