Join the Brands That Are FDA-Compliant. Your Medical Device, Cosmetic, or OTC Product Could Be Next.
Fast-track FDA compliance for Cosmetics (MoCRA), OTC Drugs, Medical Devices (510(k)/De Novo), Medical AI/SaMD, and Post-Market programs. Clear pricing. No surprises. Inspection-ready results.
Speed with Structure
Templates, checklists, and submission-ready packages designed to move fast without breaking compliance.
Correct Pathway Every Time
We scope claims, classification, evidence, and recommend the least painful pathway you can defend under scrutiny.
Survives FDA Inspection
Programs built with inspection readiness in mind: labeling control, CAPA, complaints/MDR, risk management linkages.
Proven Results Across Every Category
Real submissions. Real clearances. Real clients.
Class II Cardiovascular Monitor
510(k) cleared in 4 months. Avoided De Novo pathway, saving client $85K+ in testing costs.
✓ Cleared with zero additional info requests
Diagnostic SaMD Platform
De Novo submission for AI-powered radiology assistant. Clinical validation strategy saved 8 months.
✓ FDA clearance in 6 months
Pain Relief Topical
SPL/NDC setup + monograph alignment for multi-SKU line. Avoided Amazon delisting for non-compliance.
✓ 14 products compliant in 3 weeks
Skincare Brand (47 SKUs)
Full MoCRA facility registration, product listings, Responsible Person setup, and safety substantiation.
✓ Entire portfolio compliant for $3,200
Class III Device Remediation
Cleared 2-year MDR backlog, implemented CAPA system, prepared for FDA inspection after warning letter.
✓ Zero 483 observations at follow-up inspection
ISO 13485 Certification
Built QMS from scratch for startup. Design controls, DHF/DMR, supplier controls, internal audits.
✓ Passed certification audit on first attempt
What Our Clients Say
"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
"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, 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
Free FDA Compliance Resources
Download our expert guides—no fluff, just actionable checklists
MoCRA Compliance Checklist
Step-by-step guide to facility registration, product listings, and Responsible Person requirements. Includes timeline and cost breakdown.
510(k) Submission Guide
Complete roadmap: device classification, predicate search, testing requirements, timeline estimates, and cost ranges by device class.
OTC SPL Template & Guide
Ready-to-use SPL template, NDC structuring guide, and labeler code application walkthrough. Get your OTC products compliant fast.
✓ Instant download • ✓ No credit card required • ✓ Unsubscribe anytime
Why Companies Choose Verus FDA
We're not your typical FDA consultant
🎯 We Specialize in Small to Mid-Size Companies
Most FDA consultants only want Fortune 500 clients. We built our process specifically for companies doing $1M-$50M in revenue who need fast, affordable compliance without enterprise complexity.
⚡ Fixed Pricing, Not Hourly Billing
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.
📊 Former FDA Reviewers on Staff
Our team includes ex-FDA reviewers who know exactly what the agency looks for. We write submissions the way they want to read them—which is why our first-time approval rate is 89%.
🚀 2-Week Turnaround for Simple Projects
MoCRA listings, OTC SPL/NDC, and compliance audits done in 1-2 weeks. Complex 510(k) submissions in 2-4 months. We move fast because we've done this hundreds of times.
Get Started Fast
Transparent entry points for teams that want to get compliant quickly
Quick-Start Pricing
Transparent entry points for teams that want to get compliant fast. (Complex scopes receive a fixed quote after triage.)
- Cosmetic listing (MoCRA): $249
- OTC listing (SPL/NDC) — labeler code already completed: $249
- Labeler code + OTC listing: $600
What You Get
- Intake + compliance scoping (claims, product type, responsibilities)
- File-ready deliverables (SPL, listing confirmation, or MoCRA submission artifacts)
- Clear next steps for labeling/claims, safety substantiation, and ongoing compliance
Core Programs & Typical Pricing Bands
Pick a lane—then we tailor scope into a fixed quote based on risk, volume, and timeline.
Cosmetics & MoCRA Readiness
Typical range: $249–$10,000+
- Facility & product listings, Responsible Person setup
- Labeling/claims cleanup + safety substantiation dossiers
- Adverse event readiness + documentation programs
OTC Drugs (SPL / NDC / Monographs)
Typical range: $249–$25,000+
- Labeler code + SPL builds/updates, NDC structuring
- Monograph alignment + claims/labeling guardrails
- Manufacturer coordination + compliance checklists
Medical Devices (510(k) / De Novo / eSTAR)
Typical range: $7,500–$85,000+
- Reg pathway + predicate strategy, Q-Sub support
- Submission writing (eSTAR/510(k)) + evidence mapping
- Labeling/IFU, risk management, biocomp/EMC/test planning
Medical AI & SaMD Programs
Typical range: $5,000–$75,000+
- Intended use/claims shaping + SaMD classification support
- Clinical/RWE strategy, change control, and traceability
- Cybersecurity, privacy, and documentation readiness
QMS / ISO 13485 / Inspection Readiness
Typical range: $6,000–$60,000+
- QMS build or remediation, SOPs & records
- Design controls, supplier controls, DHF/DMR programs
- Mock audits + CAPA closure coaching
High-Risk Post-Market & Surveillance
Typical range: $4,000–$35,000+
- Complaints + MDR decisioning (21 CFR 803) + backlogs
- CAPA + trending + risk updates (ISO 14971 linkage)
- Field action/recall readiness + traceability
FDA Warning Letter Response
Typical range: $8,000–$45,000+
- Comprehensive root cause analysis + corrective action plans
- Response letter drafting + supporting documentation
- Inspection readiness + remediation program implementation
Peptides Regulatory Strategy
Typical range: $3,500–$25,000+
- Claims assessment + pathway determination (cosmetic vs. drug)
- Safety substantiation + documentation support
- Labeling review + regulatory positioning strategy
Supplements & Vitamins (Dietary Supplements)
Typical range: $2,000–$20,000+
- NDI notifications + GRAS substantiation
- Structure/function claims + labeling compliance
- cGMP readiness + adverse event reporting systems
Note: Prices shown are typical ranges and depend on product risk class, evidence gaps, complaint volume, and timeline. After a short triage call, we provide a fixed scope or milestone quote.
How We Work
A proven 4-step process to get you compliant and inspection-ready
Triage
15–30 minutes to confirm product type, claims, pathway, and urgency—then we map the smallest defendable scope.
Scope
We identify the "must-haves" (and the traps) across labeling, evidence, listings, and systems.
Build
We deliver submission-ready artifacts: SPL, MoCRA docs, 510(k) sections, SOPs, templates, and review packages.
Defend
We prepare you for FDA questions: inspection narrative, responses, CAPA linkage, and traceability of decisions.
Frequently Asked Questions
Everything you need to know about working with us
Do you provide fixed quotes?
Yes. We use these pricing bands to set expectations, then issue a fixed scope (or milestone quote) after a short triage call. No hourly billing, no surprise invoices.
What's your approval/success rate?
Our first-time approval rate for 510(k) submissions is 89% (industry average is around 70%). For MoCRA and OTC listings, we have a 100% acceptance rate because these are straightforward administrative processes when done correctly.
Can you help if we're already in trouble (FDA letter, Amazon takedown, inspection risk)?
Yes. We can prioritize stabilization: immediate labeling/claims corrections, documentation triage, submission fixes, and inspection-ready remediation. We've helped multiple clients respond to warning letters with zero follow-up findings.
Do you work with international manufacturers?
Yes—especially for OTC and device programs where the U.S. compliance owner needs a clean, auditable chain of documentation. We work with clients in 15+ countries.
How long does the typical engagement take?
Quick-start listings: 1-2 weeks. Standard 510(k): 2-4 months. De Novo: 4-6 months. QMS build: 2-3 months. Timeline depends on evidence gaps, testing requirements, and your responsiveness.
What if I'm not sure which service I need?
That's exactly what our triage call is for. We'll assess your product, claims, and situation to recommend the right pathway and scope. No obligation, no pressure.
Do you offer ongoing compliance support after submission?
Yes. We offer retainer packages for ongoing compliance management including label reviews, annual listing updates, MDR support, CAPA management, and regulatory intelligence. Rates start at $2,500/month.