‘Selected Writing: 2018’ Download It Now
‘Selected Writing: 2018’ highlights just some of the best received and most read articles from our website in the past year. It looks at an array of issues including: Repeat Use Procedures. Pharmacovigilance Audits. Brexit. Well-Established Use. Scientific Advice Meetings....
Articles from the Archive – In Case You Missed It
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 third edition of #ICYMI (In Case You Missed...
Acorn Regulatory August 2018 Newsletter
Hello and welcome to our August 2018 newsletter. This month we are featuring a new e-book from our ‘Regulatory Intelligence’ series. We also look at a number of Brexit related issues. Don’t forget that you can subscribe to our new limited...
EU MDR: What Will The Impact Be For Economic Operators?
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s....
Get ‘Regulatory Intelligence 3’ Here
Using a U.S. Dossier for a European MA Application, Well Established Use and other topics are covered in the latest edition of our regulatory magazine. ‘Regulatory Intelligence 3’ looks at a number of critical issues in today’s regulatory sector.
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Regulatory Intelligence 2 – Download It Here
Sector specialists need to stay on top of developments in the sector. That is why we have produced another edition of our e-book series. ‘Regulatory Intelligence 2’ looks at a number of the critical issues in today’s regulatory sector.
How Are Changing Regulatory Demands Impacting You?
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In...
Regulatory Affairs Industry News Roundup – June 2017
It has been a busy month at Acorn Regulatory. Here is a recap of the top regulatory affairs industry news stories for the past month. Remember, you can subscribe to our monthly newsletter here and have all of the top Acorn...
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Do You Want To Find Out About CE Marking An App? Find Out More Here
There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians – everything from medication reminders to apps which calculate drug dosage. In this brief overview we look at CE Marking an App....
