Marketing Authorisation Holders

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

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

ICYMI from Acorn Regulatory

In Case You Missed It from Acorn Regulatory: CEP’s, Orphan Drugs, Packaging & More

Our expert team has written hundreds of insightful articles on all aspects of regulatory affairs, pharmacovigilance, clinical trials, compliance and… Read more

Your eCTD Questions Answered

Acorn Regulatory’s publishing team is staffed by eCTD experts.  We have assisted many companies in their eCTD projects in recent… Read more

Acorn Regulatory April 2019 Newsletter

In the April 2019 newsletter we look at one of the most popular articles in recent years on our website. … Read more

#ICYMI Articles from the Acorn Regulatory Archive

In Case You Missed It – Articles from the Archive -#ICYMI

Welcome to this month’s edition of ICYMI from Acorn Regulatory – looking at articles from the Acorn Regulatory archive that… Read more

Articles from the Acorn Regulatory Archives

#ICYMI – Articles From The Acorn Regulatory Archives

This edition of #ICYMI from the Acorn Regulatory archives could easily be called the ‘What?’ edition.  We look at 4… Read more

The February 2019 Acorn Regulatory Newsletter

Welcome to the first newsletter of Spring!  In the February 2019 newsletter we are looking at the issue of scientific… Read more


What Are The Common Variation Validation Issues? Find Out Here

Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently… Read more

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