KIVO REGULATORY INFORMATION MANAGEMENT (RIM)
Modern RIM for today's regulatory teams.
Kivo's regulatory document management software is built for modern clinical trials. From authoring to submission building to publishing handoffs, Kivo RIM system streamlines regulatory operations.
Fully Validated
CFR Part 11 Compliant
E-Sign with Docusign
For every stage of the regulatory submission lifecycle
Kivo’s regulatory management software was purpose-built to manage the complete regulatory lifecycle for submissions and products around the globe. Our complete RIM solution gives life sciences organizations the tools & processes to confidently accelerate compliance and reduce time-to-market for new therapies, medicines, and devices.
Support for IND, CTA, BLA, NDA, IDMP, ANDA, CTIS, and more.
Advanced Content Management
Centrally manage your content - from documents to submissions to correspondence - inside the DMS, aligned to the Electronic Document Management (EDM) reference model. Import, view, and archive dossiers into Kivo with traceability.
- Easy workflow for authoring to approval
- Part 11 Compliant E-sign with docusign
- Embedded PDF conversion
- Manage user permissions & access controls
- Over 450 pre-formatted ICH document templates
- Automatic filing for correspondence, including attachments
- Reports to track document status, agency commitments, and project progress
Submission Building & Publishing Handoff
Kivo's regulatory document submission builder and publishing preparation workflows are designed for ease of use. From your first IND to your NDA, Kivo’s RIM platform accelerates the submission lifecycle while upleveling your compliance.
- Pre-built submission structures aligned to agency guidelines
- Documents link directly to the DMS
- Placeholders for single or multiple documents you’re waiting for
- Simple toggle for blinded and unblinded data
- Automatic tracking spreadsheets for publishing handoff
- One-click publishing export
Intelligent Project & Process Management
Never hear the phrase “manual tracking” again. With Kivo RIM, you can automate and templatize your content and submission planning, so you know at a glance if you are on track to meet your submission deadlines.
- Templatize your content plans and regulatory projects
- Assign due dates, task owners, dependencies, and sub-tasks
- Re-flow timelines automatically as needed according to due dates and dependencies
- Access real-time data directly within RIM reports
- Schedule reports to deliver automatically to your email
Seamless eCTD Management
Locate the right version, right away. Reduce follow-up time and gain visibility into the full submission lifecycle.With Kivo's eCTD Viewer - included with any Kivo subscription - you can easily locate the precise document or correspondence that you need.
- 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
- Maintain submission archives within the DMS for increased control
GETTING STARTED
Implementation & Migration Made Easy
Set up in weeks, not months.
Here's how it works:
- Integration & Customization: Start with our out of the-box configuration or modify to suit your process. We’ll go over your workflows in a single call - not workshop after workshop.
- Lossless Import: Easily import data from any existing system or shared folders. We capture all metadata and content, and can even create a combined audit trail.
- Unlimited Training: We’ll make sure all your users are ready to go. Grant access to new users without coming back to us, and schedule additional trainings for free.
- Automate Your Workflows: Use our built-in project and content plans to track and manage your work - and configure detailed reports for automatic delivery.
Best-in-Class Security & Compliance
Kivo’s team spent decades working with teams of all sizes on their Regulatory submissions, projects and systems. Kivo GO is trusted by more than 60 sponsors and service providers around the world, managing over 100 applications to the FDA, EMA, MHRA, Health Canada & more.
- Fully validated
- SOC 2 Compliant
- FDA 21 CFR Part 11 Compliant
- Aligned to International Council for Harmonisation, EU Annex 11, ISO 9001, GxP and GCP Guidelines.
Proud to work with customers around the globe
Kivo works with more than 60 sponsors & service providers in the U.S., Europe & Asia. Our solution currently manages over 100 active drug applications. The average Kivo customer has...
- 10.3 years in business
- 6.5 active drug programs in Kivo
- $168M in total venture & public funding
What our customers are saying
Recent Reviews
Kristi N.
VP of Regulatory Affairs
"Kivo was really fast to set up training, and then because the system is so user-friendly, it just didn’t take that much time to get people up to speed. Normally the learning curve with a system like this is quite steep, but Kivo is so intuitive we can quickly get people oriented and off to the races."
Seppe G.
Director of Regulatory Affairs and Quality Assurance
"The intuitive on-line interface has been adapted quickly by the entire development team allowing both the CMC experts as well as the clinical team to seamlessly integrate internal documents as well as controlled documents from external parties."
Veronique V.
Quality Assurance Manager
"We're very happy to have all our documents stored in the same place. It's efficient to have a system where the review of a doc can be done simultaneously by several reviewers. The Kivo team is always ready to help and always listen to customer needs. Really appreciated."
