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...
Most Read Pharmacovigilance & Medical Articles of 2019
Our pharmacovigilance and medical teams have had a busy 2019. During the course of the year they have taken the time to write some very well received articles about PV, medical and clinical issues. Here, we have compiled 4 of...
Outsourced eCTD Publishing Services: An Overview
More countries are implementing eCTD. As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services. We typically encounter three scenarios: Companies that maintain control of electronic publishing at...
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 & 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.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDEileen RyanMarketing Authorisation HoldersPharmaceuticalSubmissions
How To In-Licence An eCTD Dossier
We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully. For instance, the eCTD...
Acorn Regulatory NewsIndustry NewsMarie CarrollMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application
What is KASA and how will it impact on getting a drug assessed by the US FDA? We look at its ‘3 pillars’ and what it aims to be. Importantly, we look at how the FDA believes it will change...
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...
