Packing Up & Moving – The EMA in Amsterdam.
The transfer of a manufacturing process or technology from one plant to another within a company can be an arduous process. It involves careful consideration of the impact to the existing site and a rigorous selection process to ensure that...
‘Is Time Running Out?’ – The Sixth Acorn Regulatory Brexit Whitepaper
The course of Brexit has been filled with dramatic twists and unexpected happenings. The resignations of David Davis, Suella Braverman, Steve Baker and Boris Johnson have thrown the UK’s plans into disarray. While many of us did expect the Irish...
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...
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.
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 April 2018 Newsletter
Hello and welcome to the April edition of the Acorn Regulatory newsletter. This month we are looking at Repeat Use Procedures, Clinical Breaches and we have another of our very well received ‘Regulatory Intelligence’ e-books. The e-book is filled...
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....
Four New Countries Join The EU – US Mutual Recognition Agreement for Manufacturing Sites
Four new entrants joined the EU-US Mutual Recognition Agreement for manufacturing sites for human medicines on March 1st. The four additional countries: Czech Republic, Romania, Greece and Hungary now join the eight existing members of the agreement.
Brexit Information for the Pharmaceutical Sector
In this blog we look at a number of Brexit information resources for the pharmaceutical sector.
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