Download Our Repeat Use Procedure Slide Deck
The issue of Repeat Use Procedures generates many questions to our pharmaceutical regulatory affairs team. We have created a slide deck looking at the main points to consider when completing a Repeat Sue Procedure. You can download it below.
Download ‘Regulatory Intelligence 9’ from Acorn Regulatory
‘Regulatory Intelligence 9’ from Acorn Regulatory has a wide range of articles covering issues such as Brexit, the new Medical Device Regulations, DCP Close Outs, and more. The articles in ‘Regulatory Intelligence 9’ have been written by members of our...
What Is A Unique Device Identifier?
The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim to improve patient safety through better traceability and transparency. Both...
Acorn Regulatory NewsAdvertisingComplianceEileen ShortissHow-To & ExplainersPharmaceuticalRegulatory Affairs
How To Improve The Readability of Package Leaflets
What changes could be made to the readability of package leaflets to make them more accessible for patients? Eileen Shortiss, a Senior Regulatory Affairs Advisor at Acorn Regulatory is our in-house expert on all matters relating to package information leaflets. ...
How To Fix Common eCTD Validation Issues
Previously, we looked at issues that arise within eCTD. Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article. The article looks at Module 1 specification issues and more.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesEU Authorised RepresentativeHow-To & ExplainersMDRMedical Devices
PRRC: The 5 Responsibilities of the Person Responsible for Regulatory Compliance under MDR
This article is part of our series of MDR articles that look at the changes coming into play with the new medical device regulations. In this article, we are looking at the role of the Person Responsible for Regulatory Compliance...
How To Prepare For A PSUSA Deadline
Do you have a PSUR Single Assessment (PSUSA) submission deadline approaching? If so, our Regulatory Publishing Manager, Eileen Ryan, has prepared a helpful user guide to help you prepare for an on-time submission via the PSUR repository.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesEileen ShortissFeatured NewsHow-To & ExplainersPharmaceutical
Medicinal Product Labelling: What You Need To Know
Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label...
What You Need To Know About MRP Grouped Variations
We have written extensively on the topic of variations. The topic of MRP Group Variations arises regularly in conversations with clients. A number of clients have asked us to write about the issue. Here, we have outlined an overview on...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitEU Authorised RepresentativeHow-To & Explainers
Moving EU Authorised Representative: Find Out How To Move
Does your company currently have an EU Authorised Representative that is based in the United Kingdom? If so, your company will have to consider moving EU Authorised Representative very soon to ensure that you have representation with the European Union...
