About Verus FDA
We’re a specialized FDA regulatory consulting firm built for teams that need clarity, speed, and compliance—without enterprise complexity.
Founded on 15+ years of federal government experience, Verus helps medical device manufacturers, cosmetic brands, OTC drug companies, and digital health innovators navigate U.S. requirements with fixed-price programs, transparent timelines, and submission-ready deliverables that hold up under FDA scrutiny.
U.S.-based, supporting teams worldwide.
What to expect working with Verus
A right-sized plan, clear scope, and deliverables you can defend.
Predictable scope
Fixed pricing or milestones—no surprise billing.
Fast alignment
Early pathway decisions so labs + writing stay on-track.
Traceable documentation
Consistency across labeling, risk, testing, and submissions.
Our Mission
Make regulatory compliance accessible, predictable, and actionable—so growth teams can move fast without creating risk.
Clear Pathways
We remove ambiguity by defining the right pathway, evidence plan, and submission strategy early—so you don’t burn time or budget on the wrong approach.
Speed & Efficiency
Templates, checklists, and a repeatable workflow accelerate timelines without cutting corners. Fast means structured.
Inspection-Ready Results
Deliverables are built to withstand FDA review and inspections—documentation, controls, and traceability that defend themselves.
Transparent Pricing
Fixed quotes or milestones upfront. Clear deliverables. Clear timelines. No hourly surprises.
By The Numbers
Real submissions. Real clearances. Real impact.
Built for lean teams
We specialize in small-to-mid size companies that need senior guidance without large-firm overhead.
Designed for defensibility
Every decision maps back to claims, risks, standards, and evidence—so reviews don’t stall.
Our Approach
A straightforward method for teams that need clarity, speed, and defensible documentation.
Scope & Strategy
We assess product type, claims, documentation, and timing—then define the smallest defensible scope to get you compliant.
Evidence Roadmap
We identify standards, testing, and documentation needs—and prioritize by risk, budget, and deadlines.
Submission-Ready Artifacts
We produce ready-to-use deliverables: 510(k) sections, MoCRA, OTC SPL, QMS docs, labeling reviews, or full packages.
Support & Traceability
We prep responses, coach teams, and maintain tight consistency between documents, decisions, and controls.
What Sets Us Apart
Senior-level expertise, right-sized for growth-stage companies.
Specialized in start up-to-mid size teams
Our process is built for start ups through $100M companies who need fast, practical compliance—without enterprise complexity.
Fixed pricing, not hourly surprises
You know the cost before we start. Clear scope, clear deliverables, and a timeline you can plan around.
Work With Us
Whether you’re navigating your first 510(k), implementing MoCRA compliance, building a QMS, or remediating post-market issues— we’ll help you get it right.
General Questions
Email us and we’ll route you to the right program and next step.