KIVO REGULATORY INFORMATION MANAGEMENT (RIM)
The #1 Regulatory Management System for Life Sciences
The only RIM with real-time collaboration, lifetime validation & no hidden fees. Rated #1 easiest to use and most reviewed on G2.
Team plans start at less than $1K/month
Powering Innovative Sponsors & Service Partners Worldwide
Fully Validated
CFR Part 11 Compliant
E-Sign with Docusign
For every stage of the regulatory lifecycle
Kivo’s RIM solution lets you manage all of your key regulatory functions in an easy-to-use system that everyone can access. And unlike a ‘do-it-yourself’ file-sharing solution, Kivo is Part 11 Compliant, built on the EDM Reference Model/GxP Standards, is SOC2 Certified - and even includes eSignature via DocuSign.
Support for INDs, CTAs, BLAs, NDAs, IDMPs, ANDAs, CTIS, and more.
Quickly Organize All Your Documents
Manage all your controlled documents - from corporate content to submission materials to agency correspondence - inside Kivo's DMS, based on the Electronic Document Management (EDM) reference model. Easily import, view, and archive dossiers into Kivo with full traceability.
- Easy workflow for collaborative authoring, review & approval
- Part 11 Compliant eSignature with DocuSign
- Embedded PDF conversion
- Simple user permission & access management
- Over 450 pre-formatted ICH document templates
- Correspondence filing, including emails & attachments
- Automated reports to track document status, agency commitments, and project progress
Build Submissions & Handoff for Publishing
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 up-leveling your compliance.
- Pre-built submission structures aligned to agency guidelines
- Documents link directly to the Kivo DMS
- Placeholders to organize around expected content - single & multiple documents
- Simple toggle for blinded and unblinded data
- Automatic tracking spreadsheets for publishing handoff
- One-click export to your publishing partner or software
Keep Track of Your Team's Work
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
Easily View & Archive eCTDs
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
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."
Marissa B.
Senior Manager, Regulatory Affairs
"I have been using Kivo daily for over 2 years to manage 15+ drug development programs. It was extremely easy to learn and very intuitive for a regulatory affairs professional. Kivo makes the process incredibly easy."
Brian A.
Senior Manager, Regulatory Affairs
"Kivo is extremely user friendly, which has allowed implementation of the RIM system seamlessly throughout our company. The Kivo team has been great in walking us through the various questions we have and implementing feedback to better enhance our experience."
Lisa V
Chief Operating Officer
"The system eliminates excel spreadsheets and other trackers, providing a great summary view into content and submission planning, preparation, and completion. It's a "must have" for small companies preparing their first IND and scales well for small and mid-sized companies looking to prepare NDAs/BLAs/501Ks."
GETTING STARTED
Implementation & Migration Made Easy
Kivo's fast and flexible import tool allows our setup team to pull your documents into Kivo in a matter of days.
Set Up Kivo in Just 2 Weeks:
- Step 1: Talk with our setup team about how you’d like your Regulatory content organized. We start with the EDM Reference Model - but is fully customizable.
- Step 2: We’ll use our SFTP site and Data Migration tool to pull your documents, submissions, and correspondence into Kivo - structuring them to your specification, and can even preserve relevant metadata & merge audit history.
- Step 3: Kivo loads validation evidence into your workspace and can supply turn-key system management SOPs so that you can go live with compliant procedures and validation records.
- Step 4: Take a tour of your new Kivo system - make sure it all looks perfect.
- Step 5: After a 30-minute virtual training session, you’re ready to go. And Kivo’s support team is always available to help.
Best-in-Class Security & Compliance
Kivo’s team spent has spent decades working with teams of all sizes on their Regulatory submissions, projects and systems. Today, 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 - meaning you will NEVER need to validate our software.
- SOC 2 Compliant
- FDA 21 CFR Part 11 Compliant
- Aligned to International Council for Harmonisation, EU Annex 11, ISO 9001, GxP and GCP Guidelines.
Powering Fast-Growing Pharma Teams Around the Globe
Kivo works with more than 100 sponsors & service providers in the U.S., Europe & Asia. Our solution currently manages over 100 active drug applications.
Reduce Manual Work and Improve Compliance with the Easiest-to-Use RIM
“I can’t even express how refreshing the ease of use is, because the complexity of the traditional Part 11 Compliant systems is nonsensical. Those were designed by and for large organizations. But Kivo makes it so easy.”
-Head of IT, Elevar Therapeutics
