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Veeva Submissions Publishing

Generates compliant electronic submissions for global health authorities, integrating content plans and direct submissions from Vault.

Solution by Veeva Systems
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Overview

Overview

Veeva Submissions Publishing facilitates the creation of electronic submissions for global health authorities, ensuring compliance with current regulations through up-to-date templates and validation criteria. This system allows users to initiate the publishing process using pre-existing content plans as soon as documents reach their final stage, thereby minimizing delays.

Submissions Publishing supports the creation of both internal and external hyperlinks, allowing users to efficiently connect references within texts. Where permitted, users can publish submissions directly to health authorities from the Vault platform.

Features

  • Automated hyperlink creation for reference connections.
  • Direct submission capabilities to health authorities from Vault.
  • Dashboards and reports for tracking submission components from drafting to finalization.

Impact

This solution significantly streamlines the submission process, cutting submission creation time by 50% and shaving five weeks off NDA timelines. Additionally, users can save up to 700 hours through direct gateway submissions.

Benefits

  • Comprehensive oversight throughout the entire submission development process within a single system.
  • Enhanced efficiency and accuracy by reducing redundancy, ensuring correct document versions, and utilizing automatic tracking and transfers.
  • Faster user onboarding with on-demand training resources to remain up-to-date with new capabilities.

Customer Success

Veeva RIM is trusted by over 400 leading and emerging biopharma companies. Testimonials emphasize how it has vastly improved submission speed and quality, as well as publication process transformation through comprehensive platform capabilities.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory Affairs
Tag(s)
Quality & Compliance Management