Get FDA-Compliant Fast — MoCRA, OTC, and 510(k) Strategy That Actually Moves You Forward.
Verus FDA helps founders and operators stop guessing. We deliver clear pathways, submission-ready artifacts, and inspection-ready documentation—with transparent entry pricing and timelines.
Not sure which lane you're in? Book a quick triage call and we'll recommend the fastest defendable pathway.
Speed with Structure
Templates, checklists, and submission-ready packages designed to move fast without breaking compliance.
Correct Pathway, Defendable Scope
We scope claims, classification, and evidence so you pursue the least painful pathway you can defend under scrutiny.
Inspection-Ready Programs
Built with audit readiness in mind: labeling control, CAPA, complaints/MDR, and risk management linkages.
Start Here
Pick the offer that matches what you need right now. Clear deliverables. Fast turnaround.
MoCRA Cosmetics Compliance
From $249 • 1–3 days
- Responsible Person setup + facility registration
- Product listings + documentation checklist
- Labeling/claims quick scan (risk flags)
- Next-step roadmap (safety substantiation & ongoing)
OTC SPL / NDC Quick Compliance
From $249 • 2–3 days (active labeler code)
- SPL build/update + NDC structuring
- Labeler code support (if needed): 2–3 weeks processing
- Monograph alignment guardrails
- Submission-ready package + confirmation checks
510(k) Strategy + Predicate Review
Flat fee: $1,500 • 3–5 business days
- Predicate shortlist + comparison framework
- Pathway determination + "risk flags" before you invest
- Testing roadmap + budget + timeline estimate
- What to fix now to avoid delays later
CONTACT
Begin Your Regulatory
Partnership
Whether you're navigating your first FDA submission or seeking to optimize an established regulatory strategy, our team is ready to help you succeed.
Headquarters
1200 N Federal Hwy
Boca Raton, FL 33432
Phone
(866) 779-9719
info@verusfda.com
Schedule a Consultation
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 constraints.