Manage eCTD Lifecycles

Every aspect of lifecycle management is under your control. With the Submission Wizard, you can easily create new sequences and relate them to existing submissions.

Even append, replace and delete documents from earlier submissions by dragging files; eCTDXPress automatically sets the appropriate operation in the XML backbone. And, built-in lifecycle control allows you to keep submissions accurate and up-to-date, keeping you ahead of the latest version to come through the pipeline.

Add, Modify and Delete Metadata at Any Time
In addition to modifying metadata and adding indications and substances, you can now add regional and ICH metadata at any time during the process for greater flexibility.


Download DTD updatesAutomatic Regulatory and Compliance Updates
Getting the latest regulatory and compliance updates has never been easier. With no need for a software patch, you can import new DTD and XSL updates provided by ISI.


ISI offers comprehensive training for all types of users. From instructor-led training sessions to self-paced e-learning modules, ISI’s training solutions have you covered. Learn More


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