KIVO RIM
Documents Organized. Processes Controlled.
Streamline authoring, publishing, and lifecycle management with Kivo's Regulatory Information Management Software.
For every stage of the submission lifecycle
Authoring & Approval
Say goodbye to version control issues with Kivo’s submission management workflows. Compliance focused user permissions and access controls help build your audit trail automatically. Centralized document storage is aligned to the Electronic Document Management (EDM) reference model. Import, view, and archive dossiers into Kivo with traceability back into the Document Management System (DMS). Easily share documents with Clinical and Quality teams - no downloading and reuploading. Finally, use advanced reporting and analytics to see if you are on track at a glance.
Correspondence & Commitments
Never worry about something falling through the cracks. With a native connection to the DMS, correspondence is automatically filed in the correct location within cabinets and folders. Using customizable metadata, you can associate correspondence to projects, documents, users, agencies, and more. Finally, view all your commitments in a single dashboard.
Submission & Publishing Preparation
Kivo's submission builder and publishing preparation workflows are designed for ease of use. Assemble submissions from pre-built submission structures aligned to each country's guidelines. Create automated tracking spreadsheets to make collaborating with publishing groups a breeze. Publishers can access Kivo directly, or you can pull submissions into your existing publishing tools.
Lifecycle Management
With Kivo's eCTD Viewer, you can grant everyone in your organization access to submissions. Track where each document is used across global dossiers. Compile and manage all correspondence. And you can do it all from anywhere, with our fully browser based software.
ICH Pre-Formatted Templates
Give everyone on your team access to over 400 always-up-to-date ICH document templates. Using templates is a great way to not only improve structure and consistency - but also speed up document authoring. That’s why we built Kivo’s ICH Templates directly into MS Word - with guidance references, placeholder content, and complete customization options. Kivo's templates don't use macros to ensure they work across systems with no local install.
Support from Day 1
Implement Within Weeks
Kivo goes through a rigorous validation process to reduce the burden on your organization and reduce implementation timelines. No more implementations that drag on for months - seriously.
Unlimited Training
Receive unlimited training as long as you are a customer. We want to make sure your team is comfortable and able to get work done, so we’ll be there to help every step of the way, even when you bring on new team members.
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Real Human Support
Support is available from a real human being 5 days a week from 6am to 6pm PST. Our current response time during those hours is under 5 minutes (really!)