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Marie Carroll

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 […]

Centralised Procedure Medicinal Products: Brexit Update

How will the UK’s departure from the EU impact on medicinal products for human and veterinary health?  We have written […]

CMC Guidelines Update

Will The Updated CMC Guidelines Impact On Your Business?

Are you aware of the changes made to the CMC Guidelines on the manufacture of the finished dosage form?  We […]

Brexit & MAH Responsibilities

Brexit and MAH Responsibilities – 5 Critical Points To Consider

The spectre of a ‘no deal’ Brexit looms large in the minds of life science professionals.  What impact will this […]

Acorn Regulatory Regulatory Affairs Marketing Authorisation Variations

Focus on Variations

Acorn Regulatory’s consultants are experts in the sector.  Every day our team members are working on behalf of clients to […]

Marketing Authorisations

Marketing Authorisation Holders – An Overview

Acorn Regulatory’s consultants are experts in the sector.    Members of our team have written extensively on this website and […]

Orphan Drugs - Acorn Regulatory

Orphan Drugs: 10 Facts You Need To Know

Much has been written about orphan drugs in recent times.  These products, developed specifically to treat a rare disease, have […]

Guidelines For Notification of Serious Breaches of Regulation (EU) No. 536/2014

Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious […]

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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