We're Not Your Typical FDA Consultant
Most consultants charge by the hour and disappear after submission. We provide fixed pricing, and inspection-ready programs that actually survive scrutiny. Here's what makes us different.
What Sets Verus FDA Apart
The advantages that matter when compliance is on the line
Fixed Pricing, Not Hourly Billing
No surprise invoices. No scope creep. No "just a few more hours" charges. After a short triage call, we provide a fixed quote for the entire project. You know exactly what you'll pay before we start, and that's what you pay when we finish. Simple, transparent, predictable.
Built for Small to Mid-Size Companies
Most FDA consultants only want Fortune 500 clients with unlimited budgets. We specifically designed our process for companies doing $1M-$50M in revenue who need fast, affordable compliance without enterprise complexity. We speak your language and work within your constraints.
Speed Without Cutting Corners
MoCRA and OTC listings in 1-2 weeks. Standard 510(k) submissions in 2-4 months. We move fast because we've done this hundreds of times and have templates, checklists, and workflows that eliminate wasted time while maintaining quality and compliance.
Inspection-Ready From Day One
We don't just get you cleared—we build programs that survive FDA inspection. Every deliverable includes proper documentation, traceability, and defensibility. Our clients have a track record of passing inspections with zero or minimal findings.
Real Partnership, Not Just Transactions
We're not here to sell you the most expensive package. We scope projects to the minimum defendable compliance level, recommend cost-saving alternatives, and stay available for questions even after the project ends. Our goal is to become your long-term regulatory partner.
Deep Government Regulatory Expertise
Our team has 15+ years of Government experience across all product categories. We know exactly what the agencies look for, what triggers additional questions, and how to structure submissions for smooth review. This expertise is why our first-time approval rate is 89% compared to the industry average of around 70%.
Our Compliance Philosophy
How we think about FDA compliance differently
Minimum Viable Compliance
We believe in building compliance programs to the minimum defensible standard—not the maximum possible standard. This means you get FDA-ready faster and cheaper, without unnecessary gold-plating that doesn't add real protection. We focus on what matters and skip what doesn't.
Evidence Over Documents
Many consultants create mountains of documents that look impressive but don't actually prove compliance. We focus on creating the right evidence in the right format: test reports, risk analyses, clinical data, and traceability matrices that demonstrate safety and effectiveness, not just bureaucracy.
Inspection Narrative First
We build every program with the end in mind: what will you say when the FDA inspector asks "how do you know this is safe?" We create clear, defensible narratives that connect your claims to your evidence, your controls to your risks, and your decisions to your rationale.
Sustainable Systems
Compliance isn't a one-time project—it's an ongoing commitment. We design systems you can actually maintain without hiring a full-time regulatory team. Simple SOPs, practical checklists, and templates that don't require a PhD to use. Compliance should be manageable, not overwhelming.
Who We Work With
The companies that get the most value from working with us
Growing Brands
Start Ups to Companies with $100M in revenue who need professional FDA compliance but can't afford Big 4 consulting rates. You're past the startup phase but not yet enterprise scale.
International Manufacturers
Companies outside the US who need a reliable US Agent or compliance partner to navigate FDA requirements. We work with manufacturers in 15+ countries.
First-Time Filers
Teams submitting their first 510(k), MoCRA listing, or OTC registration who need clear guidance without regulatory jargon. We explain everything in plain English.
E-Commerce Sellers
Amazon, Shopify, and DTC brands who received compliance warnings and need to fix issues fast before getting delisted or losing sales momentum.
Post-Market Crisis Management
Companies facing FDA warning letters, inspection findings, or compliance backlogs who need immediate stabilization and remediation.
Product Developers
Teams in the design phase who want to build FDA compliance in from the start rather than retrofit it later. Smart companies plan ahead.
What Our Clients Say
Real feedback from real clients
"We were stuck for 8 months trying to figure out our 510(k) pathway. Verus mapped it out in one call and had our submission ready in 12 weeks. Worth every penny."
— Michael C.
VP of Regulatory, Medical Device Company
"The fixed pricing was a game-changer for us. No surprise bills, no scope creep. Just clear deliverables and a clear price. Finally, a consultant who doesn't bill like a lawyer."
— Jennifer L.
CEO, Cosmetics Brand
"After an FDA warning letter, we were panicking. Verus got our CAPA system fixed, cleared our MDR backlog, and coached us through the re-inspection. Zero findings."
— James R.
Quality Director, Medical Device Manufacturer
"MoCRA compliance seemed overwhelming with 60+ products. They handled everything—listings, safety files, labeling review—for less than we budgeted for one consultant day."
— Sarah W.
Founder, Skincare Line
"As an international manufacturer, we needed someone who understood both FDA requirements and how to work with overseas teams. Verus made it simple."
— David K.
Export Manager, Medical Device Manufacturer
"The team didn't just submit our 510(k)—they taught us how the system works so we can handle modifications ourselves. That's real value."
— Lisa M.
Regulatory Manager, Healthcare Technology
Why Not Choose Someone Else?
Honest answers to the alternatives
Why Not DIY?
You absolutely can do FDA compliance yourself—many companies do. But here's the reality: the learning curve is steep, the mistakes are expensive, and the time investment pulls you away from actually running your business. If you have 3-6 months to learn the regulations, make mistakes, and potentially get rejected, DIY might work. But most companies realize after a few months that they should have hired help from day one. We've helped dozens of companies fix DIY attempts that went sideways.
Why Not Big Consulting Firms?
The Big 4 consulting firms do excellent work—if you can afford $400-600/hour billing rates and enjoy working with junior staff who are still learning on your dime. They're built for enterprise clients with massive budgets. If you're a $5M company, you'll get the B-team (or C-team), and your project will take forever because they're prioritizing their bigger clients. We're built specifically for your size company.
Why Not Individual Freelancers?
Individual consultants can be great—when they're available. The problem is they're one person with limited bandwidth. If they get sick, go on vacation, or take on a bigger client, your project stalls. We're a team, which means backup, quality review, specialized expertise, and consistent availability. Plus, we have former FDA reviewers on staff—not just people who've read the regulations.
Why Not Offshore Services?
You can find cheaper overseas regulatory services, but you get what you pay for. FDA regulations are complex, constantly changing, and require native-level English and cultural understanding. We've seen countless offshore submissions that were technically compliant but poorly written, poorly structured, or missing key nuances—leading to rejections and expensive rework. For US FDA compliance, use a US-based team with US regulatory experience.
Our Commitment to You
We promise to give you honest advice, even if it means less revenue for us. We'll tell you when you don't need the expensive option, when a shortcut is acceptable, and when you're overthinking it. We'll scope your project to the minimum defendable compliance level—not the maximum possible spend. We'll provide fixed quotes so there are no surprises. And we'll stay available after the project ends because we want to be your long-term partner, not just a one-time transaction.
That's the Verus FDA difference. We're on your side.