Marketing Authorisation Holders

EU Based QPPV October 17th 2019

EU Based QPPV – Is Your Company Ready for Brexit?

As Brexit negotiations reach their most critical point, it looks today (October 17th, 2019) that a deal is in sight. … 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 To Consider When Planning To In-Licence An eCTD Dossier?

In this article we are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier…. Read more

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… Read more

No Deal Brexit Planning from Acorn Regulatory

No Deal Brexit Planning – What We Know So Far

The ongoing coverage of the UK’s moves towards leaving the European Union continues.  This is a difficult time for companies… 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

Brexit Pharma Info for the Pharma Sector

Brexit Pharma Info: Updated for 2019

The election of Boris Johnson as the new Prime Minister of the United Kingdom has put the issue of Brexit… Read more

EU Based QPPV What Happens QPPV Post Brexit

What Will Happen To The QPPV After Brexit?

Brexit will impact on many aspects of the life sciences sector.  One of the areas that will be most impacted… 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

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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