FDA Clearance & Compliance
Executed to Completion
From 510(k) medical devices to OTC drugs and MoCRA cosmetics, Verus FDA builds defensible submissions, compliant systems, and audit-ready frameworks, executed hands-on from strategy through clearance and registration.
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510(k) + eSTAR
Strategy, authoring, reviewer-ready narratives, and interactive response support.
SaMD / AI
Change control, cybersecurity, transparency, and evidence alignment.
Remediation
CAPA, 483/warning letter responses, and inspection-ready documentation.
Consumer Health
OTC + MoCRA compliance for claims, labeling, and go-to-market readiness.
Best fit for
- Teams targeting a submission window in the next 30–180 days
- Products where claims, evidence, and labeling must align tightly
- Founders who want fast, senior-level direction (not junior handoffs)
Not the best fit for
- “Just fill out the paperwork” expectations without strategy
- Projects unwilling to close evidence gaps before submission
- Teams seeking the lowest-cost provider over defendability
To protect turnaround time, we keep a limited number of active engagements. If you’re facing FDA correspondence or a near-term submission window, booking early helps secure a kickoff slot.
Speed Without Sloppiness
Structured templates + evidence mapping to reduce avoidable FDA questions and last-minute rewrites.
Defendable Strategy
Clear classification logic, predicate rationale, and claim discipline—built for reviewer clarity.
Audit-Ready Documentation
Traceable, verifiable, and inspection-ready—designed for internal reviews and external scrutiny.
Before & After: what changes when your regulatory program is built right
Before
- Unclear device classification and inconsistent intended use
- Predicate selection without documented rationale
- Gaps between claims, testing, and labeling
- Submission story is fragmented across documents
After
- Clear pathway + defendable classification logic
- Predicate framework with traceable equivalence mapping
- Claims supported by an evidence matrix + test plan
- Inspection-ready package built for reviewer clarity
Outcome
- Fewer avoidable questions and faster FDA back-and-forth
- Reduced risk of costly rework and timeline slip
- Clear internal alignment across R&D, QA/RA, and leadership
- Confidence to submit, respond, and scale
Client testimonials
What teams say after working with Verus FDA
Clearer strategy, cleaner submissions, stronger audit readiness, and less uncertainty — without wasting cycles.
“Finally — a plan that made sense.”
“They mapped our claims to evidence and closed gaps we didn’t know existed. Our team stopped guessing and started executing.”
VP, Product — Digital Health / SaMD
“Fast turnaround without cutting corners.”
“We needed a defendable strategy and clean documentation under pressure. Their structure and reviewer-ready writing saved weeks.”
Director, Regulatory Affairs — Class II Device
“We felt inspection-ready for the first time.”
“Their CAPA and remediation approach was clear, practical, and audit-proof. We walked into internal reviews with confidence.”
Quality Lead — Manufacturer
FDA Device & Strategy Expertise
Partner with FDA 510(k) specialists and medical device consultants who build defendable, inspection-ready submissions across every stage.
FDA 510(k) Submissions
Typical range: $12,500–$85,000+
- Predicate device search + risk classification strategy
- Full 510(k)/eSTAR authoring and submission management
- FDA reviewer communication + interactive response support
FDA Warning Letter Response
Typical range: $1,500–$35,000+
- Root cause analysis + CAPA development
- Corrective documentation + revalidation plan
- Response package drafting + escalation defense
Post-Market Surveillance
Typical range: $10,000–$75,000+
- Complaints, MDR, trending + signal management
- CAPA linkage and effectiveness verification
- Audit-ready post-market documentation
Risk Management & QMS
Typical range: $6,000–$60,000+
- ISO 14971 risk management file + traceability
- QMS buildout (QSR / ISO 13485)
- Internal audit prep + corrective coaching
SaMD & Digital Health
Typical range: $5,000–$75,000+
- SaMD classification + Pre-Sub readiness
- Change control and algorithm transparency
- Clinical evaluation, privacy & cybersecurity
Regulatory Advisory Programs
Typical range: $3,500–$25,000+
- Pre-submission planning + regulatory positioning
- Evidence gap analysis + testing matrix
- Custom FDA timeline, cost & pathway plan
Pricing ranges reflect project complexity, FDA communication level, and submission risk class. All engagements begin with a fixed-scope estimate and transparent milestones.
PROCESS
From Concept to Clearance
A streamlined, transparent process designed to get you to market faster.
Strategy Call
Book a brief consultation to discuss your device, timeline, and regulatory goals.
Pathway Assessment
We analyze your product classification, predicate landscape, and evidence requirements.
Build & Document
Our team authors submission-ready, inspection-proof documentation packages.
Submit & Clear
We manage FDA communication, interactive reviews, and guide you through clearance.
CONTACT
Begin Your Regulatory
Partnership
Whether you're preparing your first FDA submission or optimizing an existing program, our consultants help teams reach clearance smoothly.
Headquarters
1200 N Federal Hwy, Suite 300
Boca Raton, FL 33432
Phone
(866) 779-9719
info@verusfda.com
Schedule a Consultation
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