GDPR & Life Science Companies – 8 Things You Need To Know
The introduction, on May 25th 2018, of the General Data Protection Regulation (GDPR) continues to present a particular challenge for the life science community. The regulation was implemented to better protect the privacy of consumers data and, as such,...
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HPRA Seminar on MAH Regulatory Compliance Inspection & Advertising Compliance Programmes
Acorn Regulatory staff were among the members of a capacity audience at the HPRA seminar on MAH regulatory compliance inspection and advertising compliance programmes that was held at the Hilton Dublin on November 27th 2017.
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5 Steps To Obtain A Wholesale Distribution Authorisation Licence
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. Here, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
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Download ‘Regulatory Intelligence’ from Acorn Regulatory
Our team of regulatory affairs experts is regarded as the thought leader in the sector. They have worked on some of the most challenging and groundbreaking regulatory projects in modern times. They regularly write for specialist periodicals and speak...
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A New Approach to The Pharmaceutical Quality System
Is your quality system keeping pace with the changes in manufacturing technology and new thinking in how manufacturing companies approach the issues of quality? Many companies have adopted the pharmaceutical quality system outlined in ICH Q10 and experienced the benefits...
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Download our WDA Whitepaper
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf.
Changes to ISO 9001
At Acorn Regulatory we are committed to ensuring quality in all aspects of what we do so it’s vital to us to stay informed of updates in legislation, requirements or standards in our field of expertise – quality and regulatory....
ISO 9001:2015 – Audit Success for Acorn Regulatory
We are delighted to announce that we have successfully passed our ISO 9001:2015 annual surveillance audit conducted by NSAI on 24th March 2016. NSAI assessed our management system for its compliance with I.S. EN ISO 9001:2015 and found it to be...
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Overview of EU Regulatory Framework – Acorn Regulatory Presents at Industry Event
In the first Manufacturing Excellence event of 2016 held by County Tipperary Chamber on 12th February, Dr. Gemma Robinson (Managing Director of Acorn Regulatory) presented to a room full of Regulatory, Human Resource and Manufacturing Managers on ‘The Latest Developments in...
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Conducting Internal Audits – Guidance from our Quality Team
Our quality team has a well deserved reputation for excellence. In this blog they share their thoughts on what you need to do when conducting internal audits at your facility. Guidance on conducting Internal Audits – ISO 9001:2008 ISO 9001:2008 8.2.2...
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