Audit Defense Fund is the only organization that protects your brand and improves manufacturing efficiency — keeping you FDA audit-ready while driving revenue growth. Our mission is simple: give you the peace of mind to grow your company without the fear of an FDA audit putting it all at risk.
The FDA compliance landscape is fragmented. Companies are forced to choose between expensive one-time engagements, complex software, or reactive crisis management.
One-time mock inspections and gap analyses are expensive, and compliance gaps reopen within months without ongoing support.
$15,000 – $100,000+ per engagementPowerful platforms like MasterControl and Veeva require massive IT investment and staff training — overkill for many companies.
$50,000 – $200,000+ per yearHiring attorneys after an FDA inspection goes wrong means you're already behind. Crisis-mode lawyering is stressful and costly.
$300 – $800+ per hourOne subscription replaces fragmented consulting, software, and legal retainers with a cohesive compliance program.
Comprehensive review of your current compliance state with gap analysis, risk scoring, and a prioritized remediation roadmap.
Ongoing documentation audits, SOP reviews, and training verification to ensure you never drift out of compliance.
A customized, inspection-ready binder with all documentation, procedures, and protocols your team needs during an FDA visit.
Realistic simulated inspections conducted by former FDA personnel, complete with 483-style observation reports.
Phone and email access to experienced compliance consultants whenever questions arise — no waiting for the next scheduled review.
Included legal representation hours if you're audited, provided through our partner regulatory law firms.
Coming in Phase 2A straightforward onboarding process that gets you inspection-ready without disrupting your operations.
We learn about your facility, products, regulatory history, and current compliance posture.
Our team conducts a thorough gap analysis and delivers your risk score and remediation roadmap.
You receive your customized Audit Defense Playbook — your ready-made inspection response guide.
Quarterly reviews, on-demand support, and mock inspections keep you audit-ready year-round.
Choose the tier that fits your facility's size and risk profile. All plans include your baseline assessment and quarterly reviews.
All plans require a 12-month commitment. Founding member discounts available for early adopters.
We specialize in mid-market companies with $5M–$100M revenue who need professional compliance support without enterprise-level costs.
cGMP compliance & 21 CFR oversight
QSR, design controls & 510(k) readiness
503A/503B compliance & sterility assurance
DSHEA, cGMP & label claim verification
Multi-client compliance & audit readiness
FSMA, HARPC & preventive controls
One subscription replaces a patchwork of expensive, disconnected compliance solutions.
Schedule a free 30-minute discovery call. We'll show you how ADF keeps you FDA audit-ready while improving your manufacturing efficiency and bottom line.