operational level metrics to make improved management decisions leading
to more efficient submission projects.
-- Integrated submissions issue tracking tool to quickly resolve content
preparation issues within any node of the eCTD modules.
"We anticipate that submission content will continue to move toward a structured format, either within the eCTD standard or a future submission standard like RPS," said Woo Song, Co-Founder & Chairman, Intrasphere Technologies. "We have been working with XML and structured content for many years and it's always been a challenge to get users to become comfortable working in that environment. By building a Microsoft Office Business Application, we can now remove the complexities of XML authoring and tagging which will enable our clients to focus on efficient creation and management of submissions content, without having to learn new authoring and content management tools."
"Being able to submit documents in accordance with the FDA's rules is an obvious business-critical issue for any pharmaceutical company," said Michael Naimoli, U.S. life sciences industry solutions director, Microsoft Corp. "Companies are facing major transitions in their underlying business processes due to the new approach for eCTD. Intrasphere's PharmaCM Submission Management and Authoring solution, using Microsoft Office SharePoint Server 2007, provides firms with a seamless transition and unified way to manage and maintain the entire submissions lifecycle. This solution will enable our clients to not only meet current eCTD requirements, but also lay a long-term foundation to meet the ever-changing regulations and global demands for more structured content."
eCTD (Electronic Common Technical Document)
The eCTD standard developed by the International Conference on
Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (I
|SOURCE Intrasphere Technologies|
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