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Veeva RIM

End-to-end submission and registration management with unified regulatory information on a single cloud platform.

Solution by Veeva Systems
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Overview

Veeva RIM is a cloud-based regulatory information management platform designed for life sciences organizations. It unifies regulatory systems and processes on a single platform to support end-to-end submission and registration management. All RIM applications share a common data model, allowing regulatory business functions to operate within one Vault environment.

The platform serves as an authoritative source for regulatory documents and information globally, bringing together registration tracking, correspondence and commitments, submission document management, dossier publishing, and regulatory submission archiving in a single system.

Core RIM Applications

  • Veeva Registrations: Plans, tracks, and reports on global health authority product registrations and associated changes.
  • Veeva Submissions: A content management application used to plan, author, review, and approve regulatory submissions.
  • Veeva Submissions Publishing: Produces compliant published submissions ready to send to global health authorities.
  • Veeva Submissions Archive: Provides storage, navigation, and search of submitted regulatory applications and related correspondence and questions.

Veeva AI for Regulatory

  • Health Authority Interactions Agent: Automates health authority interactions to support faster simultaneous approvals globally.
  • Application Assistant Agent: Provides conversational insights into regulatory activities with clear and consistent narratives.

Veeva Connections (Pre-Built Integrations)

  • RIM–Clinical Operations Connection: Enables automatic sharing of product, study, and site information between systems.
  • Quality-RIM Connection: Shortens the overall timeline from change control event creation to implementation.
  • RIM–PromoMats Connection: Integrates compliance package generation for direct publishing to health authorities.

Veeva RIM is deployed as a cloud platform and supports compliance with global regulatory requirements, including EMA's IDMP implementation standards. Pre-built Veeva Connections transfer data and documents across Veeva applications, reducing manual handoffs between regulatory, clinical, quality, and promotional materials functions.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Regulatory Information Management (RIM)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
ClinicalPost-Market & RWEPreclinical / Pre-Market
Target user(s)
QA / Regulatory AffairsMedical Affairs Professional
Compliance standard(s)
21 CFR Part 11GxPICH
Tag(s)
Uses AI