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Infosys Regulatory Submission Platform

With rapidly evolving regulatory standards, life sciences organizations are focusing on meeting the changing compliance requirements. To manage regulatory submissions effectively, companies need a compliant and integrated system capable of supporting collaboration and data management.

Infosys Regulatory Submission Platform is a fully integrated Cloud-based platform with unified user experience. It strengthens collaboration and ensures simplified cost-effective regulatory submission management. To facilitate the flow of data across different business processes, the solution offers you best-in-class products integrated seamlessly with each other. It enables you to:

  • Meet the demands of changing regulatory standards through efficient reporting on real-time status of regulatory data
  • Handle, manage, and track submissions cost-effectively with support for electronic Common Technical Document (eCTD), Non-eCTD electronic Submissions (NeeS), and paper submissions
  • Ensure strong content management capabilities through enterprise-wide search capabilities
  • Manage product recalls caused by registration inaccuracies
  • Eliminate data duplication resulting from multiple systems and products
  • Disclose litigation information within an acceptable time-frame
  • Promote reuse of data across the organization with metadata management capabilities across functional units
  • Manage product creation, documentation, submissions, and regulatory tracking through seamless integration of different applications
  • Extend the platform based on your business processes
Infosys Regulatory Submission Platform

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