Regulatory Strategy

Unique Device Identifiers MDR Acorn Regulatory

How Unique Device Identifiers Will Work Under MDR

The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR apply new requirements on… Read more

Download ‘Regulatory Intelligence 6’ Now

‘Regulatory Intelligence 6’ from Acorn Regulatory is the latest edition of our e-book series that looks at the latest trends… Read more

What MAH's Need to Know About Outsourcing

What MAH’s Need to Know About Outsourcing

The continued growth of outsourcing of manufacturing in the pharmaceutical industry, and the use of more complicated supply chains means… Read more

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

Historic Dossiers Acorn Regulatory

Pharmaceutical Development for Historic Dossiers: An Overview

Getting historic dossiers registered in new markets can have its difficulties, especially when the dossier might have been developed prior… Read more

Scientific Advice Meeting Acorn Regulatory

Scientific Advice Meetings – Advice for Companies

In this article, we look at the issue of Scientific Advice Meetings.  This is an area where clients and prospective… Read more

EU MDR: What Will The Impact Be For Economic Operators?

Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation… Read more

Package Information Leaflets: An Overview

Acorn Regulatory’s consultants are package information leaflet experts.  We have a team dedicated to the creation and testing of package… Read more

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… Read more

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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