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You've been making billion-dollar decisions with half the data

The FDA's regulatory intelligence is scattered across 15 databases that have never talked to each other. Warning Letters. Adverse events. Device clearances. Enforcement history. Facility inspections. All siloed. All manually searched. None of it cross-referenced.

Until now.

SubmittalIQ is the first platform to unify every openFDA endpoint into a single queryable database, so pharmaceutical companies, CDMOs, CROs, and life sciences investors can finally ask the questions that have always been impossible to answer.

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You are about to argue your case to the FDA. Do you have the full picture?

When FDA cites a violation, they have reviewed thousands of comparable situations. They know what adequate looks like. They know what inadequate looks like. They know the difference between a response that closes a finding and one that triggers a reinspection.

Your team is writing that response without access to the same intelligence.

SubmittalIQ gives you the complete cross-referenced enforcement history: every Warning Letter, every 483 observation, every CAPA outcome across comparable companies and situations.

You have six weeks to evaluate a $300M acquisition. Here is what you are missing.

A complete regulatory risk profile of any pharmaceutical or device company requires data from at least eight separate FDA databases; drug approvals, device clearances, adverse events, recall history, enforcement actions, facility inspections, import alerts, and registration records.

That data takes weeks to manually assemble and it still misses the cross-database patterns that only appear when the data is unified.

SubmittalIQ returns a complete company regulatory profile across every product category and every FDA database in a single query. The full picture in minutes, not weeks or months.

The signal was in the FDA's data. You just couldn't see it.

Enforcement patterns precede stock movements. Adverse event spikes precede recalls. Inspection findings precede Warning Letters. Warning Letters precede consent decrees. The trajectory of a drug approval, or a manufacturing failure, is written in FDA's data months before it becomes news.

But FDA's intelligence is scattered across 15 databases that have never been cross-referenceable.

The patterns are there.

They have always been there.

They have just been invisible.

SubmittalIQ makes them visible. One platform. Every FDA database. The complete signal.

Built on the data FDA uses. Built for the organizations they regulate.

Every FDA database. Continuously updated.

SubmittalIQ ingests every openFDA endpoint — 15+ databases covering devices, drugs, biologics, enforcement, adverse events, recalls, labeling, and registrations on a continuous basis.

The data is normalized to a consistent schema and cross-referenced by company, product, and category so every query returns complete, current intelligence.

Not a snapshot. Not a sample. The full picture.

Built for regulated environments.

SubmittalIQ operates as a read-only intelligence layer.

Your organization's documents, submissions, and proprietary data never enter our system.

You query public FDA data; the same data FDA uses internally through a secure system (SOC 2 certification in progress.)

No training on your data. No exposure risk.

Shaped by the people who work with the FDA data every day.

SubmittalIQ launches July 1, 2026 with all 15+ openFDA endpoints unified and cross-queryable.

On our roadmap: AI-assisted query interpretation, company regulatory profile dashboards, enforcement signal alerts, and integration with leading regulatory information management systems.

We are building with direct input from our 18 beta testers; active FDA consultants and life sciences professionals who work with this data every day.

"For the first time I could see a company's complete FDA history; devices, drugs, enforcement, adverse events in a single query. What used to take my team six weeks took six minutes."

-You