RIM

Kivo RIM (Regulatory Information Management) is a cloud-based RIM platform designed for pharmaceutical, biotechnology, and medical device companies. It provides a centralized system for managing regulatory documents, submission planning, correspondence tracking, project management, and eCTD viewing across the full submission lifecycle. Team plans start at $1,800 per month, and the platform includes validation, CFR Part 11 compliance, and eSignature via DocuSign with no hidden fees.

Kivo RIM supports a wide range of submission types including INDs, CTAs, BLAs, NDAs, ANDAs, IDMPs, and CTIS. It is built on the Electronic Document Management (EDM) Reference Model and GxP Standards, and is SOC 2 certified and ISO 9001 compliant. The platform is used by more than 100 sponsors and service providers across the U.S., Europe, and Asia, managing over 100 active drug applications to agencies including the FDA, EMA, MHRA, and Health Canada.

Document Management Capabilities

• Manages controlled documents including corporate content, submission materials, and agency correspondence within a DMS based on the EDM reference model
• Supports collaborative authoring, review, and approval workflows
• CFR Part 11 compliant eSignature integrated via DocuSign
• Embedded PDF conversion
• User permission and access management
• Over 450 pre-formatted ICH document templates available
• Correspondence filing, including emails and attachments
• Automated reports to track document status, agency commitments, and project progress
• Full traceability for importing, viewing, and archiving dossiers

Submission Assembly and Publishing Handoff

• Pre-built submission structures aligned to agency guidelines
• Documents link directly to the Kivo DMS
• Placeholders to organize around expected content, supporting both single and multiple documents
• Simple toggle for blinded and unblinded data
• Automatic tracking spreadsheets for publishing handoff
• One-click export to a publishing partner or software

Project and Process Management

• Templatize content plans and regulatory projects
• Assign due dates, task owners, dependencies, and sub-tasks
• Automatic timeline re-flow based on due dates and dependencies
• Real-time data accessible directly within RIM reports
• Scheduled reports delivered automatically by email

eCTD Viewing and Archiving

• eCTD Viewer included with any Kivo subscription
• Designed to support eCTD 4.0
• View individual sequences, current, or cumulative views
• Easy module navigation
• Inline study tagging files
• View metadata from the DMS
• Submission archives maintained within the DMS for increased control

Platform Features

• Built on the DMS Reference Model
• Role-based, per-user licensing for full platform, limited access, and third-party access
• Smart document placeholders and drag-and-drop document upload
• Customizable authoring, review, QC, and approval workflows
• Collaboration features with customizable permissions
• Automatic audit trail
• Document linking with aliasing (no multi-indexing required)
• Intelligent analytics and reporting with customizable alerts
• Integration with Microsoft Office Online
• Customizable metadata across features
• Access to eTMF, eCTD, and QMS included with no separate integration required
• Single sign-on; fully browser-based, available for PC and Mac
• No IT required; fully cloud-based

Implementation Process

1. Discuss how regulatory information should be organized with the Kivo setup team; the system starts from the EDM Reference Model and is fully customizable
2. Documents, submissions, and correspondence are migrated into Kivo via SFTP and a data migration tool, with metadata preservation and audit history merging available
3. Kivo loads validation evidence into the workspace and can supply turn-key system management SOPs for compliant go-live procedures
4. Review the configured system to confirm it meets requirements
5. A 30-minute virtual training session is provided before go-live; ongoing support is available from the Kivo team

Security and Compliance

• SOC 2 and ISO 9001 compliant
• FDA 21 CFR Part 11 compliant
• Aligned to International Council for Harmonisation (ICH), EU Annex 11, ISO 27001, GxP, and GCP guidelines
• Validation included with the platform; lifetime validation maintained

Kivo RIM is positioned for small to mid-sized pharma and biotech teams, with implementation typically completed within two weeks. Support is provided during business hours with a stated response time under five minutes, unlimited live training, and unlimited ongoing support. The platform is recommended for teams approaching or entering clinical trials, when submission volume and cross-functional coordination outgrow spreadsheet-based tools.