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. Here, we have compiled some of the most read articles written by our team.
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.
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 the corporate and head office level
- Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
- Companies that have outsourced eCTD entirely
In this article, we will look at the benefits and the limitations presented by the three options presented above.
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 version-specific information and tool capability is crucial to import from one system to another. Try to ensure the version number of the DTD/specification is equal to or lower than the software you will be using in-house or else you may need to upgrade software when it comes time to submissions which may lead to unplanned extra costs.
Eileen Ryan, our Regulatory Publishing Manager, looks at some of the most common issues that have manifested themselves for eCTD users and she gives solutions to those problems.
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