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Whether you need help with MAUDE searches, formative study planning, recruitment screeners, or full HF report generation. We'd love to hear about your regulatory challenges.
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Whether you're a 10-person startup or a $500M medtech division, Submitta scales to your regulatory documentation needs.
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Frequently Asked Questions
What does Submitta actually cover?
More than most people expect. Automatic FDA MAUDE database searches, recruitment screener generation, formative study planning and protocols, design change support, summary of known use problems, and drafted documentation at every stage.
Are reports ready to submit?
While we pride ourselves on quality, we're not a regulatory consultant. Submitta helps you go from Human-in-the-Document to Human-in-the-Loop, so you're the one checking outputs to make sure they're ready for document control, not the one building them from a blank page.
So how much does a license cost?
If you don't use Submitta every day, why should you be charged for it? We bill you on a report-by-report basis.
How does this actually work, day to day?
You get a login. From there, Submitta is yours to use inside the privacy of your own data environment. Just a tool that's there when you need it.
Is my data secure?
Customer data is fully isolated. Submissions are never used to train or improve models across accounts. Enterprise-grade encryption, both at rest and in transit.