Download the 3rd Acorn Regulatory MDR Whitepaper
The 3rd Acorn Regulatory MDR whitepaper is available now. This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR.
Acorn Regulatory NewsBrexitChristine McGrathClinical & MedicalDanica CvetkovicGemma RobinsonMarie CarrollMarketing Authorisation HoldersPharmacovigilancePublicationsRegulatory Strategy
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.
How To Complete A Type I Variation
Type I Variations to a Marketing Authorisation are surprisingly difficult. The procedure that many people perceive to be a simple process can prove to be otherwise. This article looks at how to complete a type 1 variation and we will...
Acorn Regulatory NewsGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
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...
Acorn Regulatory NewsBrian ClearyChristine McGrathEU Authorised RepresentativeGemma RobinsonIndustry NewsPublications
Download ‘Regulatory Intelligence 5’ from Acorn Regulatory
We have published our latest e-book ‘Regulatory Intelligence 5’. This edition features a number of new articles from our expert staff. The articles look at a range of issues, many of the topics were suggested by clients or visitors to...
Acorn Regulatory NewsBrexitBrian ClearyDanica CvetkovicEU Authorised RepresentativeGemma RobinsonPublications
The Risk of No Deal Increases – ‘What Happens Next?’ – The 7th Acorn Regulatory Brexit Whitepaper
The seventh Acorn Regulatory Brexit whitepaper looks at the impact of a no deal departure from the EU on a number of sectors.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonMarketing Authorisation HoldersPharmacovigilance
Pharmacovigilance & Social Media in 2019
In 2015 we looked at the emerging role of social media in pharmacovigilance. Revisiting the topic over 3 years later we are glad to say that the field has moved on substantially in terms of research into the practical applications...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmacovigilance
How Can Remote Audits Reduce Your Pharmacovigilance Costs?
Can remote audits really reduce costs for PV departments? The remote or desktop audit is growing in popularity as client companies assess costs and the environmental impact of traveling to an audit site. Furthermore, the restrictions on movement and travel...
‘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...
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.
