Outsourced eCTD Publishing Services: An Overview
More countries are implementing eCTD. As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services. We typically encounter three scenarios: Companies that maintain control of electronic publishing at...
Acorn Regulatory Speakers Present at The RQA Ireland Conference
Speakers from Acorn Regulatory were among the speakers at this year’s annual RQA (The Research & Quality Association) conference in Dublin on October 11th 2018. Acorn Regulatory’s Gemma Robinson and Brian Cleary presented on the topic of ‘Brexit: Current Agreements...
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....
DCP Applications To Be Accepted Only in eCTD format from July 1st 2015
Looking back on how far we have progressed from the standard paper submission one thing is clear – the age of the electronic common technical document is upon us. For instance, according to the eSubmission roadmap published, as of the 1st...
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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...