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Automated Federal Submissions of a Global Pharma Provider

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Need

To conduct gap analysis and meet the operational efficiency of Submission Management Application that can also comply with the FDA submission document standards.

Solution

  • Developed an intranet site that could be accessed by submission groups worldwide.
  • Integrated with Documentum based repository
  • Developed capability to check for correct formats of documents using MS Excel, MS Word and PDF automation interfaces
  • Developed a load balancing architecture to improve performance for Word, PDF and XLS automation.

Outcome

  • Set established standard for Submissions group.
  • Increased the efficiency as well as accuracy of Submission groups by automating processes
  • Tool integrated with existing Documentum based system that can track the document lifecycle.

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