If you work in regulatory affairs, you know how complex submissions have become.One product might require dozens of sequences across multiple regions, each with unique formatting, timing, and health authority expectations.
Add in constant document updates, multiple authors and reviewers, and overlapping submission windows, and it’s easy to see why spreadsheets and email trackers break down.
This is where regulatory submission tracking software becomes essential.
Rather than scrambling to align teams and monitor status through disconnected tools, dedicated platforms give regulatory leaders the ability to see progress, manage dependencies, and prove compliance in a single place.
But choosing the right system brings up tough questions.
- What exactly does it do?
- How does it integrate with other systems? What kind of validation is required?
- And how can you be sure it’s worth the investment?
In this guide, we’ll walk through the eight most common questions life sciences professionals are asking about regulatory submission tracking software. These are the same questions regulatory leaders raise when they outgrow spreadsheets or when global filings start to multiply.
1. What is regulatory submission tracking software and how does it support life sciences teams?
Regulatory submission tracking software is designed to help life sciences organizations manage the planning, preparation, and delivery of submissions to global health authorities. At its core, it provides visibility. Instead of chasing updates across spreadsheets, email threads, and shared drives, teams can see the real-time status of every submission component in one centralized view.
This matters because submissions are rarely straightforward. A single product filing often involves hundreds of documents, dozens of contributors, and strict deadlines. Without structured tracking, version conflicts, missed handoffs, and overlooked requirements can cause delays that set programs back months or more.
With the right software, regulatory leaders gain:
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Centralized dashboards showing the progress of each submission sequence
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Automated task assignments so nothing falls through the cracks
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Linked documentation and metadata for faster cross-referencing
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Audit-ready logs that satisfy 21 CFR Part 11 and other compliance standards
The outcome is more than just efficiency. For many teams, it’s the difference between feeling like they’re constantly reacting to crises versus proactively managing a portfolio of filings with confidence.
How Kivo helps: Kivo’s Regulatory Information Management (RIM) solution brings submission tracking into the same system used for quality and clinical operations, creating one source of truth across the organization. This makes it easier for teams to manage filings with confidence and avoid costly delays.
2. How does submission tracking software ensure compliance with global regulations (FDA, EMA, MHRA)?
Compliance is the single biggest driver for adopting regulatory submission tracking software. Every submission must meet strict requirements from agencies like the FDA, EMA, and MHRA, and regulators expect clear proof that processes are controlled, documented, and auditable.
Modern submission tracking systems are built with compliance in mind. They enforce structured workflows so that every activity — from document authoring to final publishing — is captured in an audit trail. Electronic signatures, access controls, and time-stamped records create the level of traceability required under 21 CFR Part 11 and Annex 11.
The value here is twofold.
First, teams avoid the risk of noncompliance findings that can derail approvals or trigger rework.
Second, they gain confidence going into inspections. Instead of scrambling to piece together records, regulatory staff can demonstrate compliance instantly through system-generated reports.
This isn’t theoretical. Companies that have adopted purpose-built platforms often report faster health authority interactions and smoother inspections, because they can show exactly how submissions were managed and controlled at every step.
How Kivo helps: Kivo ensures compliance through built-in audit trails, secure electronic signatures, and workflows aligned to global regulatory expectations. Customers use Kivo to demonstrate inspection readiness with less effort, reducing risk and strengthening trust with health authorities.
3. Can submission tracking software integrate with my existing RIM, QMS, and eTMF systems?
Integration is one of the first concerns regulatory teams raise, and for good reason. Submissions don’t exist in a vacuum. They pull from quality records, clinical trial data, regulatory intelligence, and controlled documents. If your submission tracking software can’t connect to those sources, you end up duplicating work and introducing errors.
The legacy systems still popular today treat quality, clinical, and ETF as separate silos that have been duct-taped together. Even when you use the same company for all three verticals, you are still left reconciling documents across silos.
But this is no longer the only option for today's life sciences teams.
The most effective platforms are built around a single document management system, which powers RIM, QMS, and eTMF environments so that the same documents and metadata flow into submissions without re-entry. This eliminates version mismatches, reduces reconciliation work, and keeps everyone aligned.
The difference is clear when comparing integrated versus disconnected systems. In a disconnected setup, one group is managing SOPs in the QMS, another is updating clinical documents in the eTMF, and the regulatory team is left pulling together information manually.
In an integrated model, the submission tracker pulls from a single source of truth. Updates in one system automatically carry through to the submission package. This reduces both workload and risk, ensuring that what you send to the agency reflects the most current and compliant information.
How Kivo helps: Kivo was built on a single underlying document management system that powers RIM, QMS, and eTMF together. That means submission tracking is natively connected (rather than bolted on). The streamlined workflows enabled by this design allowed Elevar Therapeutics to scale from 10 to 20 programs in the 2 years after moving to Kivo.
4. What features should I look for in submission tracking software?
Not all platforms are built the same. The right features can determine whether a system reduces bottlenecks or simply adds another layer of administration.
Teams evaluating submission tracking software should prioritize:
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Real-time dashboards that provide visibility into submission status across products, regions, and sequences.
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Automated task and deadline management so regulatory staff aren’t stuck chasing updates.
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Configurable workflows that reflect how your organization operates, rather than forcing rigid templates.
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Version control and linked metadata to ensure everyone is working on the correct documents.
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Audit-ready logs and reports for seamless inspection readiness.
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Support for global submission formats including eCTD publishing and lifecycle management.
These features move beyond project oversight. They create a controlled environment where every submission component is traceable, compliant, and inspection-ready.
How Kivo helps: Kivo’s submission tracking capabilities are built into the same system regulatory, clinical, and quality teams already use. Instead of bolting on point solutions, Kivo provides dashboards, audit trails, and configurable workflows from day one. That flexibility has allowed life sciences teams like Elpida Therapeutics to maintain their pace on life-saving development cycles where legacy system implementation would have brought the entire company grinding to a halt for months.
5. How does submission tracking software handle multiple parallel submissions across regions?
Global programs rarely move in a straight line. A single product might be under review in the U.S. while new variations are filed in Europe and Japan, all with slightly different requirements. Managing these parallel submissions manually is where many teams hit their breaking point.
Submission tracking software helps by giving regulatory leaders a portfolio-level view. Instead of tracking each sequence in isolation, teams can see every regional filing, its current status, and the dependencies between them. Automated alerts flag when timelines overlap or when an update in one region may affect another.
This visibility is crucial for resource planning. When multiple filings move at once, staff can quickly identify bottlenecks, reallocate work, and prevent duplicate effort. More importantly, they can respond to health authority requests with confidence, knowing which sequences are impacted.
How Kivo helps: Kivo was designed to support companies moving fast across multiple regions. Teams like Hyloris have used Kivo to double their programs in just two years, because the platform gave them control over complex, overlapping submissions without adding layers of admin.
6. What are the validation requirements for regulatory submission tracking systems?
Validation is one of the most important considerations when adopting new regulatory technology. Health authorities expect life sciences companies to prove that their systems are compliant, reliable, and fit for use. For submission tracking software, this means meeting requirements under 21 CFR Part 11, Annex 11, and related GxP standards.
A validated system provides evidence that electronic records are accurate, audit trails are immutable, and workflows function as intended. Without this assurance, teams run the risk of findings during inspections that can call submissions into question.
The challenge is that traditional validation can be slow and expensive. Legacy vendors often require companies to perform extensive manual testing or revalidation whenever an update is released. This delays adoption and adds hidden costs. Modern platforms are addressing this with pre-validated infrastructure, risk-based validation approaches, and faster revalidation cycles.
How Kivo helps: Kivo’s validation framework is designed to reduce the burden on regulatory teams. The platform provides pre-validated infrastructure along with clear documentation so customers can satisfy compliance requirements quickly. Because Kivo runs quality, regulatory, and clinical on the same system, updates only require one round of validation instead of duplicating effort across multiple tools.
7. What are the costs and ROI of regulatory submission tracking software?
Cost is always a factor when evaluating new systems, especially for growing biotechs that need enterprise-grade compliance without enterprise-sized budgets. Pricing models for submission tracking software vary. Some vendors charge per user, others per module, and many add significant fees for implementation, validation, or integration.
The return on investment usually comes from two areas:
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Time savings: Less manual tracking, fewer delays, and faster turnaround on submissions.
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Risk reduction: Lower chance of missing deadlines, losing version control, or failing an inspection.
The financial impact of avoiding a delay in market entry or a failed inspection can far outweigh licensing costs. The key is to look beyond sticker price and consider how much rework, consultant support, or staff time you’ll save.
How Kivo helps: Kivo was built to make enterprise compliance affordable for life sciences teams. By combining submission tracking with RIM, QMS, and eTMF in one system, customers avoid the costs of maintaining multiple platforms or running duplicate validations. Companies like Elevar chose Kivo because it simplified operations at scale without the heavy overhead of legacy vendors.
8. Are there examples of life sciences companies successfully using submission tracking software?
Most regulatory leaders want to see proof before making a decision. Case studies provide that evidence, showing how teams like theirs have used submission tracking software to solve real problems. The most compelling examples highlight not just features, but measurable outcomes — faster submissions, smoother inspections, and the ability to scale programs without adding headcount.
For emerging biotechs, these stories matter even more. They need to know that systems can support them at their current stage while still being flexible enough to grow. Large pharma companies often ask the same question from a different angle: can the software handle the complexity of global programs without creating silos?
How Kivo helps: Kivo customers include organizations at every stage. Elpida used Kivo’s GxP solution to manage life-saving submissions under urgent timelines. SSI partnered with Kivo to establish a quality and regulatory foundation that emerging biotechs could trust. Hyloris doubled their programs in just two years by scaling regulatory, clinical, and quality together. And Elevar completed 19 TMF migrations in 72 days while simplifying submission operations.
Next Steps
Regulatory submission tracking software is no longer a “nice to have.” As programs expand across multiple regions, and health authority expectations become more rigorous, spreadsheets and email chains can’t keep pace. The right system helps teams stay inspection-ready, avoid delays, and manage complexity without adding unnecessary overhead.
The eight questions in this guide reflect the issues most regulatory leaders face when considering a platform: compliance, integration, features, validation, cost, and proof that it actually works in the real world.
The answers point to a simple truth: effective submission tracking comes from a system that’s flexible enough to adapt to your processes while strong enough to deliver enterprise-grade compliance.
That balance is what Kivo was designed for. With one underlying document management system powering regulatory, quality, and clinical, teams gain a single source of truth for submissions, audits, and inspections. Customers across biotech, pharma, and medtech have used Kivo to scale confidently while avoiding the high costs and rigidity of legacy vendors.
If your team is reaching the limits of spreadsheets or outgrowing disconnected tools, now is the time to explore how a unified platform can transform the way you manage submissions.
