Pharmaceutical

Acorn Regulatory Repeat Use Procedure Slide Deck

Download Our Repeat Use Procedure Slide Deck

The issue of Repeat Use Procedures generates many questions to our pharmaceutical regulatory affairs team.  We have created a slide… Read more

TOPRA Webinar NI Protocol Acorn Regulatory

Watch The Northern Ireland Protocol Webinar

Acorn Regulatory hosted a webinar in association with TOPRA on March 4th, 2021 to look at the issue of the… Read more

MIA licence Manufacturers and Importation Authorisation Ireland from Acorn Regulatory

Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence

Acorn Regulatory has obtained a Manufacturer’s / Importer’s Authorisation (MIA) licence  (otherwise known as an MIA Licence) for Batch Certification… Read more

DCP Closure Acorn Regulatory

How to Move from a DCP Close Out To Product Launch

When a Decentralised Procedure (DCP) or a Mutually Recognised Product (MRP) process is drawing to a close, much of the… Read more

GUIDE TO IMPROVING PACKAGE LEAFLET READABILITY

How To Improve The Readability of Package Leaflets

What changes could be made to the readability of package leaflets to make them more accessible for patients?  Eileen Shortiss,… Read more

Drug Device Combination Products Acorn Regulatory

What You Need To Know About Drug Device Combination Products

The European medical devices regulation (MDR) 2017/745/EC was published on 5th May 2017 and has updated significantly the requirements for… Read more

Guidance for MAHs Covid 19

Expectations for Human Use Products During The Covid-19 Pandemic

The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency… Read more

 COVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work.

The Competent Authorities Response to Covid-19

COVID-19 has transformed almost every aspect of our daily lives. Nevertheless,  patient safety must remain a priority. COVID-19 may force MAHs… Read more

orphan drug Acorn Regulatory

Updated for 2020: Development of the Orphan Drug Sector

The orphan drug pipeline continues to grow and the sector has attracted considerable interest.  We have updated this article for… 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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