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PROTECT REGULATORY SUBMISSIONS FOR EXTERNAL & INTERNAL SHARING

Powered by the ROSETTA Phoenix™ eCTD Viewer

The optional ShareVault eCTD Viewer, currently in beta, allows for efficient review of biopharma regulatory submissions, such as IND (investigational new drug) applications and NDAs (new drug applications), in eCTD (electronic common technical document) format. The viewer, developed jointly with DoubleBridge Technologies, Inc., is based on the industry-leading ROSETTA Phoenix eCTD Viewer, and is seamlessly integrated within the ShareVault web application:

  • Organize your submission documents into a secure, centralized repository along with other important documents for sharing with external third parties or for secure internal sharing
  • Securely share eCTD submission documents with partners, regulatory advisors, CROs, CMOs and other third parties
  • All eCTD submission data are protected with ShareVault's industry-leading document control features
  • Automatically detects eCTD submissions published to ShareVault, marking them with the ROSETTA Phoenix icon
  • Users click the ROSETTA Phoenix icon in the ShareVault web application to open the submission documents directly into the Rosetta Phoenix viewer
  • Clicking hyperlinks to documents within the submission will instantly open the appropriate document within the viewer (if the user has been granted permission to the target document)
  • Compliant with the latest eCTD specifications and backwards-compatible with previous specifications from ICH and Canadian, E.U., Japanese, Swiss, Taiwanese, and U.S. regions
  • Intuitive visual indication for lifecycle operations, status and history
  • Supports both implicit and explicit lifecycle operation models

“I initially used ShareVault to organize and securely share confidential documents with external parties. ShareVault's user-friendly interface, end-to-end security and document controls gave us confidence that documents were secure in any situation. I also expanded my use of ShareVault as a central corporate repository to organize pre-clinical and clinical trial information which I frequently needed to access. Having one central repository supporting multiple use cases eliminated the need to learn and log in to other company systems saving time in my busy day."

— Chris Primiano, Sr. VP Corporate Development,
General Counsel and Secretary Karyopharm

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