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...
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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.
Do You Need A WDA? Here Is What You Need To Know
There has been an increase in the number of companies that have sought our services to assist them in obtaining a WDA. If your company needs a WDA, we can assist you with the process in a timely and professional...
Wholesale Distribution Authorisation: Updated Guide for 2020
There has been significant growth in the number of companies seeking a pharmaceutical Wholesale Distribution Authorisation in Ireland (WDA) in recent years. We have assisted many companies with every step of the process. Our Quality team works with companies from...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMandy CashmanQuality Management SystemWDA
Need A WDA? Read Our Step By Step Guide
There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years. We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining...
Acorn Regulatory NewsIndustry NewsMarie CarrollMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
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? We look at its ‘3 pillars’ and what it aims to be. Importantly, we look at how the FDA believes it will change...
Acorn Regulatory To Speak at RQA Ireland Forum 2019
We will be speaking at the 2019 RQA Ireland Regional Forum on May 23rd at The Kingswood Hotel in Dublin. The 2019 event will focus on the theme of ‘Chain Reactions & Interactions’ and will look at the uncertainty that...
Acorn Regulatory NewsComplianceIndustry NewsPharmaceuticalQuality Management SystemRegulatory Affairs
What Are The Benefits Of Smart Packaging In The Pharma Sector?
Much has been written about the benefits of smart packaging for the pharmaceutical sector. The introduction of smart packaging technologies is regarded as another step in safeguarding the security of medicinal products and devices. Below, we look at smart packaging...
Documented Information Procedures – What You Need To Know Ahead of The Deadline
ISO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that have not yet upgraded to the revised standard, the ISO 9001:2008 certification expiry date will soon be approaching. Control of...
Our WDA E-Book Is Available To Download Now
The issue of wholesale distribution authorisations or wholesale dealer authorisations (WDA) remains a hot topic in regulatory and quality circles. For many, the issue of Brexit has ‘muddied the water’ somewhat. Anecdotal evidence would suggest that there has been a...
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