Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesCompliancePharmaceuticalQuality Management SystemVeterinaryWDA
Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence
Acorn Regulatory has obtained a Manufacturer’s / Importer’s Authorisation (MIA) licence (otherwise known as an MIA Licence) for Batch Certification of Imported Medicinal Products for Veterinary Use.
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...
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsHow-To & ExplainersIVD DevicesMDD DevicesMedical Devices
Steps to CE Marking an IVD Medical Device
One of the most frequent questions we are asked is: how do you CE mark an IVD device? We will look at the steps that you need to take to obtain when CE marking an IVD device. As the new...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitMarketing Authorisation HoldersPharmaceuticalPharmacovigilance
EU Based QPPV – Is Your Company Ready for Brexit?
As Brexit negotiations reach their most critical point, it looks today (October 17th, 2019) that a deal is in sight. The EU and the UK have agreed a deal and the UK Parliament are now set to vote on the...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMandy CashmanQuality Management SystemWDA
Need A WDA? Read Our Step By Step Guide
There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years. We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersPharmaceuticalPharmacovigilance
Updated: How To Prepare For A Pharmacovigilance Inspection
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared.
What Are Post Authorisation Safety Studies?
Post authorisation safety studies (PASS) are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures. In...
