Regulatory Affairs

The Acorn Regulatory Brexit Guide No. 1 Revised for 2020

We published our first Brexit guide in July 2016.  Back then, we looked at the potential implications for the life… Read more

How To Improve The Readability of Package Leaflets

What changes could be made to the readability of package leaflets to make them more accessible for patients?  Eileen Shortiss,… Read more

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… Read more

Most Read Pharmaceutical Articles of 2019

Our expert team has written hundreds of well received and widely shared articles in recent years.  This year, they wrote… Read more

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… Read more

Applying For A WDA? Follow These 5 Steps

The issue of Wholesale Distribution Authorisations has been a hot topic for companies for many years.  We work with a… Read more

‘Selected Writing from Acorn Regulatory’ Download It Here

‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the… Read more

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

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… Read more