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 applies new requirements on… Read more

Download ‘Regulatory Intelligence 6’ Now

‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector. You can download your… 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

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 before… Read more

Scientific Advice Meeting Acorn Regulatory

Scientific Advice Meetings – Advice for Companies

Scientific Advice Meetings are an area where clients and prospective clients consistently seek our support.  Our expert team has significant… 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

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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