Collaborative Submissions

Collaborative Submissions is a comprehensive, collaborative environment for the authoring, review, approval, assembly, export and long-term management of all regulatory documents and submissions. Combining a full document management feature set, rich metadata support, huge scalability and a wide range of secure, collaborative business process tools, it is the premier integrated submissions environment solution.

  • Combine document management and submission publishing in a single, global environment for all team members with controlled roles and permissions

  • Manage all submission types, from content creation to publication and submission

  • Track submission status on a rolling basis though the full lifecycle, before and after applications are submitted

Open Text Collaborative Submissions delivers this functionality with the following components:

Supplemented by Business Content (e.g., predefined workflows) to give you a head-start in configuring workstreams and processes, Consulting Services, Training and Support tailored to meet your requirements.

 
 

Key Performance Indicators

Shorter time to submission in all jurisdictions

Reduced re-work and enhanced submission quality to improve review success

 

 

Webcasts & Podcasts

eCTD and Collaborative Submissions
In 2008, eCTD will be the preferred electronic format for regulatory submissions to the FDA.  This session covers industry challenges, eCTD trends and the product history of Livelink ECM - Collaborative Submissions.  A brief case study is also presented in this recorded session.

Electronic Submissions - Pharmaceutical and Life Sciences Industry
This podcast discusses industry trends towards electronic submissions and the benefits of the eCTD format.

 

 

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