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Regulatory Advisory Programs

Retained FDA strategy and execution for medtech, AI/SaMD, OTC drugs, and cosmetics. Built to reduce compliance risk, accelerate submissions, strengthen reimbursement readiness, and keep you inspection-ready.

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Transparent pricing ranges. No instant checkout. Defined scope, response expectations, and deliverables.

Programs How it works Apply

Programs

Select the program that matches your stage. Pricing ranges reflect complexity and cadence. Click “Apply” to start intake and confirm fit.

Tier 1 • Compliance

Compliance Monitor

For OTC brands, cosmetic companies, small device firms.

$1,500–$2,500/ month

Quarterly label review updates
Annual establishment registration reminders
SPL/NDC monitoring
MoCRA updates
One compliance call per month
Email access (48-hour response)

This is your “sleep at night” package.

Steady compliance coverage and predictable access for ongoing questions.

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Tier 2 • Growth

Device Growth Partner

For funded medtech or AI device startups.

$4,000–$7,500/ month

Ongoing 510(k) support
Predicate watch alerts
Regulatory strategy calls (2/month)
Software change control advisory
QMS light oversight
Commercialization strategy check-ins
Investor-ready regulatory summaries

Aligns with VC-facing positioning and fast-moving development cycles.

Guardrails for rapid execution with investor and FDA scrutiny in mind.

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Tier 3 • Inspection-Ready

Inspection-Ready Program

For revenue-stage device companies.

$8,000–$15,000/ month

Ongoing ISO 14971 review
IEC 62304 oversight
Cybersecurity monitoring
Mock inspection quarterly
CAPA review
Labeling change impact analysis
Direct FDA communication support

This is your fractional VP of Regulatory model.

Built to keep you audit-proof with proactive inspection prep and documentation control.

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Market Access

FSA / HSA + Reimbursement Subscription

Recurring revenue through recurring compliance.

$2,000–$5,000/ month

IRS 213(d) review updates
Truemed-style documentation support
NDC alignment review
Insurance strategy roadmap updates
Quarterly reimbursement eligibility refresh
ICD-10 alignment review

Positioned for brands scaling through FSA/HSA and broader reimbursement pathways.

Ongoing eligibility maintenance and reimbursement planning to protect growth.

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AI / SaMD

AI & SaMD Regulatory Intelligence Club

AI Device Compliance Network.

$1,000–$2,000/ month

Monthly AI regulatory brief
FDA enforcement updates
AI policy change alerts
Cybersecurity SBOM updates
Closed-door strategy call (group format)

Scales efficiently with high margin and consistent demand.

Stay ahead of AI compliance shifts with structured monitoring and updates.

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510(k)

510(k) Build Plan

Pipeline subscription for predictable runway.

$5,500 +/ month (4–12 months)

Predicate search
Testing plan development
Risk file drafting
eSTAR build in phases
Submission prep

This smooths cash flow and makes the “yes” easier.

Structured monthly execution plan toward submission readiness.

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Cosmetic / OTC

Cosmetic & OTC Brand Protection Club

Cosmetic Compliance Shield.

$1,200–$2,000/ month

Ingredient watch
Claims review
Amazon compliance support
Retail readiness checklist
Ad claim monitoring
Adverse event SOP oversight

Built for MoCRA, claims discipline, and retail pressure.

Ongoing coverage to reduce claims risk and keep you retail-ready.

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Investors

Investor Readiness Subscription

FDA Strategy for Fundraising.

$2,500/ month

Regulatory roadmap deck updates
510(k) probability analysis
Clinical necessity memo
Due diligence support calls
Investor Q&A prep

Structured narratives investors expect in diligence.

Translate your regulatory plan into an investable story with defensibility.

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Hotline

Regulatory Hotline Membership

FDA Access Pass.

$750–$1,250/ month

2 quick calls/month
Email support
Basic compliance questions
Claim reviews

High-volume, low-lift membership option with clear boundaries.

Ideal for quick gut checks and ensuring small decisions don't create big risks.

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How it works

Step 1 Submit your details via the intake form to confirm fit and capacity.

Step 2 We'll conduct a brief assessment to finalize the tier and scope that fits your roadmap.

Step 3 Formalize the retainer and begin your structured advisory engagement.

Ready to start?

Current advisory capacity is limited. Applications are reviewed within 48 hours for mutual fit.

Complete Intake Form