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How To Fix Common eCTD Validation Issues

How To Fix Common eCTD Validation Issues

by elena@investinu.ie | Jul 13, 2020 | Acorn Regulatory News

Previously, we looked at issues that arise within eCTD.  Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article.  The article looks at Module 1 specification issues and more. We have outlined some additional guidance on eCTD validation...
The 3 Options for eCTD Publishing & Submission Services

The 3 Options for eCTD Publishing & Submission Services

by elena@investinu.ie | Jul 7, 2020 | Acorn Regulatory News

The transition from paper-based submissions to the more costly eCTD system has caused many companies to reconsider how they undertake regulatory publishing.  Acorn Regulatory was an industry leader in the early adoption of eCTD technology in 2014 and we have worked...
The FDA Move from Paper to Electronic DMFs

The FDA Move from Paper to Electronic DMFs

by elena@investinu.ie | Jun 22, 2020 | Acorn Regulatory News

The transition from paper-based submissions to electronic Common Technical Document (eCTD) has continued in recent years.  This is something that we have covered on this website on a number of occasions.  The US FDA no longer accepts paper-formatted DMFs.  The FDA...
How To Fix Complications with UUID Numbers in eCTD

How To Fix Complications with UUID Numbers in eCTD

by elena@investinu.ie | Jun 12, 2020 | Acorn Regulatory News

Acorn Regulatory’s publishing team is staffed by eCTD experts.  We have assisted many companies in their eCTD projects in recent years.  Many visitors to our website submit questions on regulatory issues. Issues with UUID numbers arise time and again and we are...
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