Regulatory Solutions

Accelerate regulatory submission publishing process

Seamlessly incorporate publishing capabilities within Veeva RIM Suite to dramatically speed submission delivery. Vault Submissions Publishing moves document publishing activities upstream during authoring and away from late-stage submission finalization. The software utilizes a continuous publishing process, which performs validation behind the scenes, allowing medtech companies to identify issues earlier when they are easier to fix.

Benefits

Comprehensive Oversight

Comprehensive oversight of the end-to-end submission development process within a single system.

Streamlined Process

Streamlined processes with access to the correct documents without manual tracking or transfers.

Greater Efficiency

Shorter timelines because publishing steps are completed earlier during submission authoring and approvals.

Unified RIM

Connect end-to-end regulatory processes and improve efficiency with the Vault RIM Suite.

Features

Assisted Submission Building

Eliminate manual steps with rule-based auto-matching. Leverage documents and metadata found in submission content plans.

Submission Independent Hyperlinking

Create hyperlinks that are independent of the submission structure so they can be used earlier in the process during document reviews and reused across multiple submissions.

Background Validation

Automate validation and link testing with a behind-the-scenes service that identifies problems as submissions are being built.

Submission-Ready Rendering

Automatically render all documents with the correct PDF standards. Navigate web links, cross references and tables of contents directly from the viewer.

Real-time Status Reporting

Visibility into the complete submission process, including submission status and individual document readiness.

Resources for Vault Submissions Publishing

Image for Single Authoritative Source for Regulatory Submissions Content from Planning to Authoring to Assembly
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Single Authoritative Source for Regulatory Submissions Content from Planning to Authoring to Assembly

Image for How Epredia transformed quality and regulatory operations with Veeva MedTech
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How Epredia transformed quality and regulatory operations with Veeva MedTech

Image for Lori Holder shares how Vault RIM provides a single system to automate Alcon’s regulatory processes
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Lori Holder shares how Vault RIM provides a single system to automate Alcon’s regulatory processes

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Industry Insight: Current State of Modernization in Regulatory Affairs