How To Fix Common eCTD Validation Issues
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.
The 3 Options for eCTD Publishing & Submission Services
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...
The FDA Move from Paper to Electronic DMF’s
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 DMF’s. ...
How To Fix Complications with UUID Numbers in eCTD
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...
Acorn Regulatory’s Essential Guide to eCTD & Electronic Publishing
We have worked with companies around the world on electronic publishing and eCTD issues for many years. Acorn Regulatory has its own dedicated publishing team, led by Eileen Ryan, and they assist our clients on an ongoing or ad-hoc basis. ...
How To Prepare For A PSUSA Deadline
Do you have a PSUR Single Assessment (PSUSA) submission deadline approaching? If so, our Regulatory Publishing Manager, Eileen Ryan, has prepared a helpful user guide to help you prepare for an on-time submission via the PSUR repository.
Get The Latest eCTD Publishing Whitepaper Now
Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing. Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download.
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...
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How To In-Licence An eCTD Dossier
We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully. For instance, the eCTD...
What’s Happening with the eSubmission Roadmap?
The eSubmission roadmap is filled with significant dates that can impact on your business. Here, we look at developments on the eSubmissions roadmap up to 2020.
