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.
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
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.
FAQs
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.
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