We handle the regulatory complexity
so you can focus on innovation.
60+ years of combined tech, product, and pharmaceutical regulatory expertise, built into one platform. We eliminated the regulatory friction we used to fight through. Now you can too.
Meet the team.
Regulatory, engineering, security, and design. The overlap is what makes it work.
22+ years in pharmaceutical regulatory affairs with deep expertise in FDA vaccine and biologics licensure. Led regulatory strategy for CMC, lifecycle management, and complex BLA submissions. Brings firsthand experience navigating FDA interactions from pre-IND through post-approval.
30+ years leading pharmaceutical operations, product development, and medical affairs at AbbVie, Johnson & Johnson, Baxter, Fresenius Kabi, and Elusys Therapeutics. Deep expertise in oncology, biosimilars, and biologics commercialization. Currently COO at Direct Biologics and Board Member at Radyus Research.
Principles, not slogans.
Honesty is the product.
A gap analysis that shows no gaps is worse than no gap analysis. When something is missing or uncertain, we show it, because the credibility of the output depends on it.
The expert stays author of record.
AI accelerates the work. The regulatory professional who reviews, edits, and signs off on the output is the author. We're built to amplify that person, not replace them.
Every assertion carries its receipt.
If a line in the draft can't trace to a source document, it doesn't belong in a submission. We don't generate confident-sounding statements; we generate provable ones.
Meet the people behind the platform.
Bring your hardest regulatory question. You'll be talking to people who've sat on your side of it.
- Walkthrough on your nonclinical or clinical source data
- See gap detection and sentence-level traceability live
- No prep required, around 30 minutes
Thanks — we'll be in touch.
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