FDA Compliance That Holds Up Under Review — Fast, Practical, Inspection-Ready
We help brands and manufacturers ship compliant products and defend them under scrutiny—across Cosmetics (MoCRA), OTC Drugs (SPL/NDC), Medical Devices (510(k)/De Novo/eSTAR), Medical AI/SaMD, and high-risk post-market programs.
Speed with Structure
Templates, checklists, and submission-ready packages designed to move fast without breaking compliance.
Correct Pathway
We scope claims, classification, evidence, and the "least painful" pathway you can defend.
Inspection-Ready
Programs that survive audits: labeling control, CAPA, complaints/MDR, and risk management linkages.
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
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.
Trusted by Brands Across All Categories
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.
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.
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.
How long does the typical engagement take?
Quick-start listings can be completed in 1-2 weeks. More complex submissions (510(k), De Novo) typically range from 2-6 months depending on evidence gaps and testing requirements.
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.
Start With a Quick Call
Tell us what you sell (cosmetic / OTC / device / software), where you're stuck, and your timeline. We'll reply with a sequenced plan and a quote aligned to your scope and urgency.
📍 Based in Charleston, SC
🌍 Supporting teams worldwide
Prefer direct email? info@verusfda.com