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 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.
The UK PSMF – What Will It Look Like?
How will the Pharmacovigilance System Master File (PSMF) be impacted by the UK’s departure from the EU? What actions will companies with a UK Marketing Authorisation Holder (MAH) need to take in the event of a no-deal Brexit? We consider...
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 NewsChristine McGrathHow-To & ExplainersMarketing Authorisation HoldersRegulatory Strategy
What MAH’s Need to Know About Outsourcing
The continued growth of outsourcing of manufacturing in the pharmaceutical industry and the use of more complicated supply chains means that in certain situations the Marketing Authorisation Holder (MAH) can become very far removed from manufacturing process and products. However,...
What Will Happen To The QPPV After Brexit?
Brexit will impact on many aspects of the life sciences sector. One of the areas that will be most impacted will be the role of the Qualified Person for Pharmacovigilance (the QPPV). In this article, we consider the impact that...
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 NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory Affairs
UPDATED: What Are The Initial Steps in Applying for a Marketing Authorisation?
We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA). In this article we aim to provide a guide to assist companies applying for an MA We have also provided a number of links throughout...
Acorn Regulatory NewsAuditEU Authorised RepresentativeHow-To & ExplainersIVD DevicesMDD DevicesMedical Devices
EU Authorized Representative – Find Out What You Need To Know As Brexit Nears
In recent months we have assisted a large number of companies in transferring their EU Authorized Representative from the UK and into another EU country. Companies with an EU Authorized Representative in the UK have been forced to appoint a...
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