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.
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...
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...
Acorn Regulatory NewsEileen ShortissHow-To & ExplainersPharmaceuticalRegulatory AffairsRegulatory Strategy
Can Improvements Be Made To The Readability of Package Leaflets?
We look at the possible changes that could be made to package leaflets to improve their comprehension and readability.
Guidelines For Notification of Serious Breaches of Regulation (EU) No. 536/2014
Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious breach of EU regulation No. 536/2014. The European Medicines Agency describes the regulation as: The goal of Clinical Trial Regulation EU No....
Acorn Regulatory NewsGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Is Well Established Use Going Out of Fashion?
The choice of legal basis is one of the most crucial choices that a Marketing Authorisation Holder must make. One of the choices available, ‘well established use’ seems to waning in popularity as a choice amongst MAH’s. Here, we look...
Brexit Information for the Pharmaceutical Sector
In this blog we look at a number of Brexit information resources for the pharmaceutical sector.
Blog: The UK Life Science Strategy Sector Deal & The Role of Regulatory Affairs
While the UK government may not have carried out sectoral analysis of the impact of Brexit, it has developed a comprehensive industrial strategy that seeks to become the road map for the UK’s place in a global economy post Brexit. ...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
How To Develop A Regulatory Strategy: An Overview
The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy. A carefully crafted regulatory strategy is crucial when a pharmaceutical company wishes to market its medicinal product across regions subject...
