Easily Manage Regulatory Projects & Submissions

Most of the tools advertised for regulatory project management are simple task trackers. The best software goes deeper, designed for the complexity of global submissions, traceability requirements, and the need to align cross-functional teams. Life sciences companies need more than Gantt charts or Jira-style boards. They need a system that ties regulatory plans directly to the content, approvals, and compliance workflows that drive submissions forward.

Kivo was built for exactly this purpose. Unlike generic PM tools or rigid enterprise platforms, Kivo provides structured yet flexible project tracking tied directly to your DMS and RIM system. Teams can define their submission plan, assign responsibilities, monitor content status in real time, and generate submission-ready outputs within a system that’s Part 11 compliant and purpose-built for regulatory use.

Kivo empowers regulatory and clinical project managers by bringing together content, timelines, and team accountability into one unified platform. Instead of juggling spreadsheets, shared drives, and disconnected PM tools, project managers can oversee submission progress directly within the system that houses the actual documents. With Kanban views, Gantt-style timelines, and task templates purpose-built for life sciences workflows, Kivo makes it easy to assign responsibilities, track progress, and keep cross-functional teams aligned.

Beyond tracking tasks, Kivo provides real-time visibility into the true status of each document, not just whether someone marked it “in progress.” Because Kivo integrates task management with document lifecycle workflows, project managers always know which content is still in drafting, what’s awaiting review or approval, and whether submission modules are on track. With built-in reporting, version control, and compliance features like Part 11-ready e-signatures, Kivo helps project managers deliver complex submissions on time and in full compliance, without chasing updates or risking versioning errors.

Yes, Kivo is designed to handle large-scale, complex regulatory submissions with a fully integrated approach to regulatory project management. Whether you're managing an IND, NDA, BLA, MAA, or multiple global submissions in parallel, Kivo combines submission planning, content tracking, and document management in a single, validated system. Project managers can define submission timelines, assign owners, and track readiness across all modules and markets.

With built-in templates for different submission types, role-based access controls, and real-time reporting, Kivo helps teams collaborate efficiently and stay audit-ready. You can monitor document status, manage cross-functional workflows, and generate export-ready packages without switching between disconnected tools. By embedding regulatory project management directly into the submission process, Kivo gives teams the control, visibility, and scalability needed to deliver complex submissions on time and in full compliance.

Kivo maintains compliance throughout the regulatory project lifecycle by embedding control, traceability, and auditability into every step of the process. Every action, from document creation and editing to review, approval, and export, is logged in a complete audit trail that meets 21 CFR Part 11 and GxP requirements. Version control is automatic and enforced, so teams always work from the correct document without the risk of outdated or duplicated files. Every document is linked to its metadata and approval history, giving regulatory project managers full transparency into the status and history of each submission artifact.

In addition to document-level controls, Kivo also applies compliance rigor at the project level. Task assignments, due dates, approvals, and role-based access are all tracked and enforced within the system, ensuring that every stakeholder sees and interacts only with the content relevant to their role. This helps reduce risk, improve inspection readiness, and streamline internal and external audits. To learn more about Kivo’s validation approach, security protocols, and compliance posture, you can visit our Trust Center.

Kivo’s regulatory project management tools are purpose-built for the unique needs of life sciences teams, not retrofitted from generic project management platforms. We tie project milestones, tasks, correspondence, and submission content directly to your underlying regulatory documents within a single, validated system. That means project managers aren’t just tracking progress in abstract terms; they’re monitoring real-time status tied to the actual work being done, with full visibility into which documents are approved, pending, or at risk.

Unlike most tools that require separate systems for project planning, content management, and compliance tracking, Kivo brings it all together in one seamless workflow. You can manage submission timelines, assign responsibilities, track agency communications, and generate up-to-date reports without ever leaving the platform. Because Kivo was designed specifically for regulatory professionals in pharma, biotech, and med device companies, it supports your existing processes while providing the structure and traceability required for GxP compliance and audit readiness. It’s more like a regulatory command center than a simple project management tool.