Expectations for Human Use Products During The Covid-19 Pandemic
The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency have developed a ‘questions and answers’ document in light of the ongoing Covid-19 pandemic. The aim of the document is...
Download our CMC e-book Now
Acorn Regulatory’s team of CMC, pharmacovigilance, quality, clinical and medical devices experts consistently produce articles for the sector. In the CMC e-book, we have compiled some of the most-read articles into a downloadable PDF. In this CMC e-book, we will...
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Download ‘Regulatory Intelligence 6’ Now
‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector. You can download your edition of the e-book by completing the form below.
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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...
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Centralised Procedure Medicinal Products: Brexit Update
How will the UK’s departure from the EU impact on medicinal products for human and veterinary health? We have written an overview that, we hope, will serve as a handy guide. The Q & A document “Questions and Answers to...
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...
Brexit and MAH Responsibilities – 5 Critical Points To Consider
The spectre of a ‘no deal’ Brexit looms large in the minds of life science professionals. What impact will this have for the Marketing Authorisation Holders? In this blog, we look at some of the key areas that will affect...
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Focus on Variations
Acorn Regulatory’s pharmaceutical regulatory affairs consultants are experts in the sector. Every day our team members are working on behalf of clients to ensure that their variations are completed in as timely a manner as possible. Members of our team...
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...
Orphan Drugs: 10 Facts You Need To Know
Much has been written about orphan drugs in recent times. These products, developed specifically to treat a rare disease, have become more common in the marketplace. At the time of writing (May 2018) there are almost 300 orphan drugs commercially...
