);

Pharmaceutical

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.  […]

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 […]

Pharmacovigilance Inspection Acorn Regulatory

Updated: Pharmacovigilance Inspection: Read Our Guide & Be Prepared

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to […]

What Are The Key Factors To Consider When Planning To In-Licence An eCTD Dossier?

In this article we are taking a look at 4 key factors to consider when planning to in-licence an eCTD […]

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 […]

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 […]

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 […]

Marketing Authorisation Initial Steps in Applying for a MAH

UPDATED: What Are The Initial Steps in Applying for a Marketing Authorisation?

Editor’s Note:  The original version of this article was our most read article of 2017. Because regulatory professionals need access […]

‘RQA Ireland Conference – Chain Reactions & Interactions – Review

Acorn Regulatory was the main sponsor for the 2019 RQA Ireland Conference held at the Kingswood Hotel, Citywest on May […]

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
©2019 Acorn Regulatory Consultancy Services Ltd. Company Registration No. 397294 VAT Registered No. IE 6417294V
Designed by