Accelerate Regulatory Submission Timelines

The best regulatory submission software balances compliance, speed, and flexibility. While legacy systems like Veeva Vault RIM offer robust capabilities, they can be costly and rigid, especially for smaller or mid-sized teams. Other options may lack true end-to-end integration or require heavy customization.

Kivo was purpose-built to be the sweet spot between spreadsheets and enterprise systems. It offers enterprise-grade compliance with a modern, user-friendly experience (no six-month configuration cycles or overbuilt tools). We give your team the flexibility to structure your submissions your way, while eliminating common versioning, duplication, and revalidation headaches.

Regulatory authorities like the FDA and EMA have strict formatting, content, and traceability requirements. Submission software helps ensure that your documents meet these standards and that your team follows a repeatable process. From preclinical INDs to commercial NDAs and MAAs, software ensures that submission content is correctly structured, tracked, and version-controlled.

Kivo supports submissions to both U.S. and global authorities. Our pre-formatted templates and submission structures map to standard requirements, and our export tracking features help streamline your transition to publishing, reducing last-minute scrambles and missed details.

Submission software should make it easy to track what’s complete, what’s pending, and what’s changed, without managing everything in a spreadsheet. It should also ensure that the versions being submitted are the correct, final versions approved internally.

Kivo does this natively. Our Submission Builder links directly to your DMS content, so version history is automatic and updates are visible in real time. You can generate export trackers on demand and stay aligned with publishing timelines without manually checking every document’s status.

Yes, any regulatory submission software used in a validated environment must be compliant with 21 CFR Part 11, which governs electronic records and signatures. Compliance ensures data integrity, secure access, and audit trails.

Kivo is fully Part 11 compliant, with built-in electronic signature capabilities, role-based access controls, and complete version and audit history. Our system is validated and trusted by life sciences teams across pharma, biotech, and med device, helping them meet FDA, EMA, and other global requirements with confidence.

Absolutely. Kivo is built to support the real-world collaboration that regulatory submissions require: across departments, external partners, and global teams. You can assign roles and permissions to internal contributors, external consultants, and publishers, ensuring each stakeholder has the right level of access without compromising data integrity or compliance.

Real-time collaborative authoring is available directly in Microsoft Word, so multiple team members can work on the same document simultaneously, no downloading, emailing, or version control headaches. Whether you’re coordinating across time zones or reviewing content with a CRO, Kivo ensures everyone is working from a single source of truth. Every edit is tracked, every version is captured, and every approval is auditable.

Kivo is designed to make outsourced publishing fast, clean, and frictionless. Whether you're working with an external publishing vendor or a remote regulatory operations team, Kivo gives you the flexibility to manage handoffs your way without disrupting your internal workflows.

You can grant controlled, read-only access to publishers directly within Kivo, allowing them to view and export the exact documents needed without duplicating files or waiting on email attachments. Alternatively, you can generate a structured ZIP export that includes the full submission package or just the files that have changed since the last export, complete with metadata and folder hierarchy intact.

Because Kivo tracks source content in a single validated system, publishers always receive the most current, approved versions, eliminating the back-and-forth that often comes with file mismatches or outdated drafts. This saves valuable time during crunch periods and minimizes the risk of submission errors or rework.

Most submission tools need to integrate with external QMS or RIM systems to function properly, which can create delays, version conflicts, and complex validations. Kivo is different. Our platform includes fully integrated QMS, RIM, and eTMF capabilities, all built around a single, validated DMS.

That means you don’t need to sync or transfer documents between systems. Your submission content is already in the right place, with the right metadata, ready to be pulled into your Submission Builder. It’s faster, simpler, and more traceable.

Most regulatory submission software stops short of full publishing, requiring a separate tool or vendor to create eCTD-ready outputs. Some larger systems include publishing but are overly complex or require extensive configuration.

Kivo was built to streamline the path to publishing. While we integrate seamlessly with publishing tools, we also provide export-ready content tracking and structured outputs to simplify the handoff to your publishing team or vendor. By eliminating upstream content confusion, we make the final steps far less painful.