Everything you need to know about ADF

Audit Defense Fund is a subscription-based FDA compliance service that combines proactive compliance preparation with reactive legal defense coverage. We keep your company inspection-ready year-round through ongoing monitoring, mock inspections, and expert guidance — all for a predictable monthly fee.

ADF is built for FDA-regulated companies in the $5M–$100M revenue range. Our typical clients include pharmaceutical manufacturers, medical device companies, compounding pharmacies, nutraceutical producers, contract manufacturers, and food & beverage companies.

These companies are too large to ignore compliance but too lean to justify $200K enterprise platforms or six-figure consulting engagements.

Traditional consultants deliver a one-time snapshot: they come in, assess your compliance, hand you a report, and leave. Within months, compliance gaps reopen as personnel change and processes evolve.

ADF is an ongoing subscription. We don't just assess you once — we monitor continuously, review quarterly, and keep your Audit Defense Playbook current. Plus, we're building toward included legal defense coverage that no consultant offers.

QMS platforms like MasterControl and Veeva are powerful but require significant IT implementation, staff training, and ongoing administration. They give you the tools but not the expertise.

ADF provides the expertise directly. We review your documentation, conduct your mock inspections, and advise your team — without requiring you to implement and maintain complex software. Many of our clients use ADF alongside simpler quality tools.

Our baseline assessment is a comprehensive review of your current compliance state. It covers documentation and SOPs, quality systems, training records, facility practices, CAPA programs, and regulatory filings. You receive a compliance risk score, a detailed gap analysis, and a prioritized remediation roadmap.

Our mock inspections are conducted by former FDA investigators who simulate a real inspection — including document requests, facility walkthroughs, and employee interviews. Afterward, you receive a 483-style observation report that mirrors real FDA findings, along with remediation recommendations.

Professional plan members receive one mock inspection per year. Enterprise members receive two.

The Audit Defense Playbook is a customized, inspection-ready guide built specifically for your facility. It includes role assignments, document retrieval procedures, investigator interaction protocols, and post-inspection response templates. It's your team's go-to resource when the FDA arrives, and it's updated quarterly to stay current.

All members get access to experienced compliance consultants via email. Professional and Enterprise members also get direct phone access with priority response times. There's no ticket system or chatbot — you reach a real compliance expert who understands your facility and your regulatory profile.

ADF offers three tiers: Essentials at $1,500/month, Professional at $3,500/month, and Enterprise at $6,500/month. Annual billing discounts are available: 7% off Essentials ($16,740/yr), 10% off Professional ($37,800/yr), and 13% off Enterprise ($67,860/yr).

Yes, all plans require a 12-month commitment. This ensures we have the time to complete your baseline assessment, deliver your Audit Defense Playbook, and establish the quarterly review cadence that keeps you consistently compliant.

Compliance is not a one-time event — and a subscription model only delivers value with continuity.

No. Your subscription covers everything included in your tier — baseline assessment, quarterly reviews, Audit Defense Playbook, on-demand support, and mock inspections (Professional and Enterprise). There are no surprise invoices, no hourly add-ons, and no scope creep charges.

You can upgrade your plan at any time during your subscription — the price difference is prorated. Downgrades take effect at the start of your next billing cycle. Contact us to discuss which plan best fits your current needs.

From your first discovery call to being fully covered takes approximately 30 days. This includes your baseline assessment, delivery of your Audit Defense Playbook, and setup of your quarterly review schedule. We work around your operations so there's minimal disruption.

During the discovery call, we'll discuss what documentation and access we'll need. Typically this includes current SOPs, quality manuals, recent audit reports, organizational charts, training records, and facility access for the baseline assessment. We provide a detailed checklist after you sign up.

Yes, the baseline assessment and mock inspections require on-site visits. These are scheduled in advance and coordinated with your team to minimize operational disruption. Quarterly reviews and ongoing support are conducted remotely unless an on-site review is warranted.

Legal defense coverage is planned for Phase 2 of our rollout. We're currently finalizing partnerships with regulatory law firms that specialize in FDA enforcement actions. Phase 1 members will be the first to receive this benefit when it launches.

Legal defense coverage will provide included attorney hours for FDA enforcement actions — including 483 response drafting, warning letter responses, consent decree negotiations, and enforcement action defense. Coverage will be provided through our partner regulatory law firms who specialize exclusively in FDA matters.

Legal defense hours will be included in your subscription at no additional cost. The specific number of included hours will vary by plan tier. Additional hours beyond what's included will be available at preferred rates through our partner firms.