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In July 2001, the International Conference on Harmonisation (ICH) defined a set of specifications for a paper dossier required for the registration of medicines, known as the Common Technical Document (CTD). Shortly thereafter, in 2003, they defined the electronic version, the eCTD. As of 2008, the eCTD will be the only kind of electronic submission for drug applications acceptable to the Center for Drug Evaluation and Research (CDER).
These developments present new challenges to drug manufacturers. As electronic submissions are required instead of paper, how will your organization adapt to these changes?
The eCTD differs from other electronic submission formats because it is defined by an XML backbone. While this feature greatly enhances the organization of the submission, it can also be daunting for those involved in its preparation. i4i is pleased to offer its eCTD creation and lifecycle management tool, eCTD Manager. Let i4i's expertise and experience in XML technology and document management guide your organization to the implementation of a successful eCTD preparation and submission protocol.
The eCTD Manager is an extension to capabilities offered through ALiCE, i4i's Authoring Lifecycle and Collaboration Environment. As such, it stays fully connected to your document repository. With your documents always at hand, the building of the submission is possible much sooner in the drug product application lifecycle. Building the eCTD becomes as simple as managing your documents.
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