);

Pharmaceutical

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 […]

Acorn Regulatory Co Tipperary Chamber Manufacturing Excellence

Acorn Regulatory To Present At ‘Manufacturing Excellence 2019’

Experts from Acorn Regulatory will be presenting at the ‘Manufacturing Excellence 2019’ event at the Questum Centre, Clonmel, Co. Tipperary […]

Acorn Regulatory To Speak at RQA Ireland Forum 2019

We will be speaking at the 2019 RQA Ireland Regional Forum on May 23rd at The Kingswood Hotel in Dublin.  […]

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 […]

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