About VerusFDA
We're a specialized FDA regulatory consulting firm built for companies that need clarity, speed, and compliance without enterprise complexity.
Founded on 15+ years of real federal government experience, VerusFDA exists to make regulatory compliance accessible, predictable, and actionable for medical device manufacturers, cosmetic brands, OTC drug companies, and digital health innovators navigating U.S. market requirements.
Based in West Palm Beach, Florida, we support teams worldwide with fixed-price regulatory programs, transparent timelines, and submission-ready deliverables that survive FDA scrutiny.
Our Mission
Clear Pathways
We eliminate regulatory ambiguity by identifying the right pathway, evidence requirements, and submission strategy from day one—so you never waste time or budget on the wrong approach.
Speed & Efficiency
We've built templates, checklists, and proven processes that accelerate timelines without sacrificing quality. Fast doesn't mean reckless—it means structured and repeatable.
Inspection-Ready Results
Every program we deliver is built to withstand FDA review and inspection. We don't just get you cleared—we ensure your documentation, systems, and controls can defend themselves.
Transparent Pricing
No hourly billing surprises. We provide fixed quotes or milestone pricing upfront, so you know exactly what you're investing and what you'll receive in return.
By The Numbers
Real submissions. Real clearances. Real impact.
Our Approach
We work with small to mid-size companies ($1M-$50M in revenue) who need expert FDA guidance without the overhead of large consulting firms. Our process is built for clarity, speed, and defensibility.
Triage & Scope
We start with a focused assessment: product type, claims, current documentation, and timeline. Then we map the smallest defendable scope that gets you compliant.
Evidence & Planning
We identify what testing, standards, and documentation you need—and help you prioritize based on risk, budget, and submission deadlines.
Build & Assemble
We deliver submission-ready artifacts: 510(k) sections, MoCRA listings, OTC SPLs, QMS documents, labeling reviews, or complete compliance packages.
Defend & Support
When FDA asks questions or inspections loom, we prepare responses, coach your team, and ensure traceability between documents, decisions, and controls.
What Sets Us Apart
Specialized in Small-to-Mid Size Teams
Most FDA consultants only want Fortune 500 clients. We built our entire process specifically for companies doing $1M-$50M who need fast, affordable compliance without enterprise complexity.
Fixed Pricing, Not Hourly Surprises
You know exactly what you'll pay before we start. No surprise invoices, no scope creep, no "just a few more hours" charges. One price, one deliverable, one timeline.
Work With Us
Whether you're navigating your first 510(k), implementing MoCRA compliance, or remediating post-market issues, we're here to help you get it right.
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