Pharmaceutical

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… Read more

eCTD Electronic Publishing Acorn Regulatory

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result more companies are being forced to make decisions regarding how their manage… Read more

EU Based QPPV October 17th 2019

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. … Read more

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… Read more

Pharmacovigilance Inspection Acorn Regulatory

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… Read more

What To Consider When Planning To In-Licence An eCTD Dossier?

In this article we are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier…. Read more

MRP Grouped Variations

What You Need To Know About MRP Grouped Variations

Previously, we have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations… Read more

What is KASA FDA

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?  In this article we… Read more

Using A U.S. Dossier for a European MA Application

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… Read more

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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