How To Prepare for Remote Audits
Current restrictions on travel, brought about by Covid-19, have resulted in the increase in remote audits being carried out by health authorities. While there might not be an auditor sitting across a meeting room table from you, there are still...
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 deck looking at the main points to consider when completing a Repeat Sue Procedure. You can download it below.
Update on the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)
The new veterinary medicines regulation (Regulation (EU) 2019/6) will come into force in January 2022. It will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union. The new regulation seeks to simplify the...
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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 Northern Ireland Protocol from a consultancy standpoint. The webinar was a fully booked event and generated significant interest among regulatory...
Acorn Regulatory to Present TOPRA Webinar on Northern Ireland Protocol
Janet Fitzgerald, Regulatory Project Manager at Acorn Regulatory, will present on the consultancy approach to the Northern Ireland Protocol in a TOPRA webinar on March 4th at 1.00 pm. The presentation will focus on experiences dealing with the impact of...
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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 of Imported Medicinal Products for Veterinary Use.
Download our Clinical Evaluation Report Slide Deck
The most significant change from the MDD to the MDR is the increased focus on clinical evaluation, access to data, and post-market surveillance. This places a greater burden upon manufacturers and their representatives, and it is something that we, at...
Download Our Northern Ireland Protocol Pharmaceutical Guide
How will the Northern Ireland Protocol impact companies in the pharmaceutical sector? That is a question that we have been asked many times in recent months. The issue of the Northern Ireland Protocol has continued to be a source of...
Download Regulatory Intelligence 10 from Acorn Regulatory
Regulatory Intelligence 10 from the award-winning experts at Acorn Regulatory looks at issues from the pharmacovigilance, medical devices, clinical and pharmaceutical sectors. You can download your copy of the latest guide in the Regulatory Intelligence series by completing the form...
Download Our MDR Changes Slide Deck
The new medical device regulations will be introduced in May 2021. The MDR changes will see an increased set of responsibilities for manufacturers, economic operators, authorised representatives, and distributors. Our MDR regulatory affairs consultants are currently working with companies to...
