FDA Services & Pricing
Transparent, fair-market starting prices. Government fees are separate and billed at cost. Final quotes depend on scope and complexity.
Small Business Determination (FDA) may reduce certain device submission fees. Rush options available.
Cosmetics (MoCRA)
| Service | Details | Starting Price |
|---|---|---|
| Facility Registration | Setup & validation for one facility | $450 |
| Cosmetic Product Listing | Per formula/shade family (MoCRA) | $129 each |
| Label / Packaging Review | PDP, INCI order, warnings, net quantity | $395–$795 |
| Safety Substantiation Memo | Literature review & rationale per formula | $650–$1,250 |
| INCI & EU Allergen Check | Restricted/prohibited ingredient screening | $395 |
| Website / Claims Review | Cosmetic vs drug line-drawing; social/ads | $495–$895 |
OTC Drugs
| Service | Details | Starting Price |
|---|---|---|
| Establishment Registration (DRLS) | Annual; SPL gateway setup | $650 |
| NDC Labeler Code Application | DUNS alignment & SPL starter files | $650 |
| Drug Listing (SPL) | Per NDC; initial or change submission | $295–$495 each |
| Drug Facts Label Review | Format compliance; monograph fit | $495–$995 |
| Monograph Fit & Strategy Memo | Eligibility vs non-monograph/NDA | $650–$1,250 |
Medical Devices
| Service | Details | Starting Price |
|---|---|---|
| Classification & Predicate Scan | Product code, regulation, pathway analysis | $950–$1,950 |
| Q-Sub / Pre-Sub Package | Briefing book, questions, meeting support | $3,500–$6,500 |
| Breakthrough Device Request | Strategy + full submission | $6,500–$12,500 |
| 510(k) (eSTAR) Authoring | Complete build, testing matrix, submission mgmt | $18,000–$38,000 |
| De Novo Submission | Risk-benefit, special controls, clinical strategy | $45,000–$85,000 |
| PMA Planning / Sections | Structured plan or targeted modules | $65,000–$150,000 |
| UDI / GUDID Setup | Account, DI/PI data, labeling map | $750–$2,500 |
Full Submission Services
| Service | Description / Scope | Starting Fee |
|---|---|---|
| Full 510(k) Submission | End-to-end regulatory support: predicate selection, strategy, submission (eSTAR or traditional), FDA communication, labeling, testing coordination, and deficiency responses. | From $20,000 |
| Traditional 510(k) | Full-service traditional 510(k) with all supporting documentation, validations, and one FDA response cycle. | From $25,000 |
| Special / Abbreviated 510(k) | For modifications or standardized submissions leveraging consensus standards or existing clearances. | From $15,000 |
Review, Gap, & Pre-Submission Services
| Service | Description / Scope | Starting Fee |
|---|---|---|
| 510(k) Review & Gap Analysis | Detailed review of draft 510(k), identifying deficiencies, documentation gaps, and FDA expectations. | From $5,000 |
| Pre-Sub (Q-Sub) Meeting Preparation | Briefing package, risk/benefit justification, Q&A deck, and meeting summary for FDA engagement. | From $6,000 |
| 510(k)-Exempt Device Classification | Confirm exemption status, documentation under 21 CFR Parts 862–892, and labeling alignment. | From $3,000 |
| 510(k)-Exempt Compliance Package | Exemption confirmation letter, labeling review, registration, and QMS conformity documentation. | From $6,000 |
Food & Dietary Supplements
| Service | Details | Starting Price |
|---|---|---|
| Food Facility Registration (FFR) | New or renewal; US agent add-on available | $395 |
| FSVP Program (Importer) | Hazard analysis, supplier approval, procedures | $2,500–$6,500 |
| Supplement Label Review (21 CFR 101) | Supplement Facts, claims, disclaimers | $495–$995 |
| cGMP (21 CFR 111) SOP Set | Core SOP package (customized) | $2,500–$4,500 |
| Structure/Function Claim Substantiation | Evidence review & memo | $1,250–$2,500 |
Quality Systems & Audits
| Service | Details | Starting Price |
|---|---|---|
| QMSR / 21 CFR 820 Gap Assessment | Remote doc review + prioritized plan | $2,500–$6,500 |
| ISO 13485:2016 Gap & Roadmap | Stage-0 prep for certification | $3,500–$8,500 |
| Supplier Audit (Remote) | Checklist, report, CAPA recommendations | $1,750 |
| Internal Audit Program | Plan, templates, training | $2,500–$5,500 |
| CAPA / Complaint / AE Procedures | SOPs + forms tailored to risk | $1,250–$3,500 |
Website, Marketing & Content Reviews
| Service | Details | Starting Price |
|---|---|---|
| Mini Review (1–2 pages) | Homepage or PDP + short memo of fixes | $295 |
| Standard Site Review (up to 8 URLs) | Findings deck + redline recommendations | $695 |
| Comprehensive Review (up to 20 URLs) | Full matrix, corrected copy, disclaimers, ad policy map | $1,450 |
| Ongoing Content Vetting (monthly) | Up to 15 assets/mo; 48–72h SLA | $1,200/mo |
Documents, Plans & Training
| Service | Details | Starting Price |
|---|---|---|
| Regulatory Strategy Memo | Target market, pathway, testing plan | $950–$2,500 |
| Clinical/Performance Test Plan (Device) | Endpoints, acceptance criteria, stats framework | $2,500–$7,500 |
| Labeling / IFU Pack | IFU draft, symbols, UDI mapping | $1,250–$3,500 |
| Recall & Field Action Procedure | Decision tree + forms | $1,250–$2,250 |
| Adverse Event / Reporting Guidance | Workflow & reporting triggers (FAERS/MDR) | $850–$1,950 |
| Consultation (50 min) | Targeted Q&A or live document review | $295 |
| Hourly Consulting | Discounted 10/20-hour blocks available | $250–$325/hr |
| Team Workshop (2 hrs) | FDA basics tailored to your products | $1,250 |
| On-Site Support (Day Rate) | Audits, remediation, training (plus travel) | $2,400–$3,200/day |
Amazon & Marketplace Readiness
| Service | Details | Starting Price |
|---|---|---|
| Listing & Store Policy Review | FDA-sensitive claims, restricted products | $395–$795 |
| Compliance Pack | Certificates/attestations, safety statements | $350–$650 |
| Regulatory Response / Appeals | Draft responses, citations, corrective actions | $450–$950 |
Notes & Disclaimers
| Item | Details |
|---|---|
| Scope | Pricing reflects common scopes for startups to mid-market; enterprise/complex products may require custom quotes. |
| Government Fees | FDA/MDUFA and other agency fees are separate. Small Business Determination may reduce certain FDA fees. |
| Turnaround | Rush & weekend options +25–40% depending on timeline. |
| Revisions | Most fixed-fee items include one revision round within 14 days of delivery. |