SUBMISSION ASSEMBLY
Accelerate Regulatory Submission Timelines
Designed for life science teams working with outside publishing, Kivo RIM makes submission assembly simple.
Authoring & Approval Simplified with Regulatory Compliance
Speed up submission processes while ensuring compliance with Kivo.
Kivo’s Submission Builder was designed to accelerate the way you work while maintaining compliance. We’ve built smart, lightweight features that speed up or eliminate manual workflows altogether. Start with pre-formatted templates and pre-built submission structures. Link your content directly from the DMS so you are always aware of new versions or document updates. And automatically generate export tracking, to streamline your handoff to publishing as deadlines approach.
SUBMISSION ASSEMBLY
An EDMS for Emerging Life Sciences
Kivo partners with emerging life science companies, who typically outsource their publishing. As such, we've expressly designed a simple export process for submissions. Grant access directly to your publisher or send them a zip file via their preferred transfer method.
Features
Submission Assembly Include:
DMS Reference Model
Never start a submission from scratch. Kivo includes pre-built submission structures for common submission types, including placeholders, to give you an immediate boost.
Link Content to the DMS
Submission content links directly to the DMS. Easily filter for documents with updated versions, so you spend less time following up with team members.
Automatic Export Tracking
Every export includes an automatic tracking sheet that shows what documents have been newly added, updated, or deleted. Export only changed files, or include everything.
Pre-Formatted ICH Templates
Add on over 450 pre-formatted ICH templates, as well as upload or customize your own unique templates for cover letters and other use cases.
Part-11 Compliant Workflows
Make reviewing, approvals, and e-signatures easy to collaborate on and obtain. Convert to PDF and flatten, all within Kivo.
Controlled Access
Easily grant or revoke access to submissions at any time, from internal team members to third party vendors to your publisher, speeding up collaboration while maintaining compliance.
Accelerate Your
Workflow with Kivo
See how Kivo can help your team reduce manual work and improve compliance.
FAQs
Kivo’s regulatory solutions are ideal for emerging life sciences companies that outsource publishing and need efficient, compliant submission assembly processes.
Kivo speeds up workflows with pre-built submission structures, direct DMS content linking, automatic export tracking, and pre-formatted ICH templates.
Yes, Kivo is designed with part-11 compliant workflows to ensure regulatory compliance for submission approvals, e-signatures, and document handling.