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Since 2008, eCTD (Electronic version of the Common Technical Document) is the only kind of electronic submission for drug applications acceptable to the Center for Drug Evaluation and Research (CDER). With submissions having to be electronic, drug manufacturers must consider new methodologies and adapt their organization to change.
The eCTD, now defined by an XML backbone makes it different from other electronic submission format. While the XML backbone greatly enhances the organization of the submission, it can also be daunting for those involved in its preparation.
i4i's expertise in XML technology and document management can guide your organization in eCTD preparation and submission protocol leading to a successful implementation. Take advantage of i4i's recognized leadership in delivering XML-based solutions for the authoring and lifecycle management of SPL-compliant submissions. i4i is strongly committed to the life sciences industry's focus on patient safety, providing deep XML expertise to the development of industry guidance and education.
The ALiCE eCTD manager uses the document management foundation offered by ALiCE, i4i's Authoring Lifecycle and Collaboration Environment. With your documents always at hand, the building of the submission is an on-going process that can begin early in the drug product lifecycle. The eCTD Manager is fully connected to your document repository so building and maintaining the eCTD is as simple as managing your documents.
Through a rich, yet simple-to-use interface, users can:
- Insert files into the eCTD hierarchy from their local drive, or from content stores managed through ALiCE.
- Preview the content of files instantly.
- Publish previews.
- Automatically populate folder contents based on pre-defined criteria.
- Update an entire eCTD status at the click of a button.
- Manage version submissions and links.
- Check for submission readiness warning and errors.
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