Every service is designed to keep you inspection-ready year-round, eliminate compliance gaps before they become audit findings, and improve your manufacturing efficiency.
Before we can protect you, we need to know where you stand. Our baseline assessment is a comprehensive, ground-up review of your entire compliance posture — documentation, SOPs, training records, facility practices, and quality systems.
You'll receive a detailed risk score, a gap analysis mapped to current FDA expectations, and a prioritized remediation roadmap with clear timelines and accountability.
Compliance isn't a one-time event — it drifts. Personnel change, processes evolve, and regulations update. Our quarterly reviews catch the gaps before an FDA investigator does.
Each review includes a structured audit of your documentation, SOP currency, training records, CAPA status, and any changes to your operations since the last review. You receive a written report with actionable findings.
When the FDA arrives, your team needs to know exactly what to do, who speaks, where documents are, and how to manage the process. Our Audit Defense Playbook is your customized, inspection-ready guide for that exact moment.
This isn't a generic template — it's built specifically for your facility, your products, and your regulatory profile. Updated quarterly to stay current.
The best way to prepare for an FDA inspection is to experience one. Our mock inspections are conducted by former FDA investigators who know exactly what to look for, what questions to ask, and where companies typically fail.
You'll receive a 483-style observation report that mirrors real FDA findings — giving you the chance to remediate before it counts.
Compliance questions don't follow a schedule. When you need guidance on a supplier qualification, a process change, a labeling question, or an unexpected regulatory inquiry — you need an expert now, not next quarter.
Every ADF member gets direct access to experienced compliance consultants via phone and email. No ticket systems, no waiting.
If an FDA inspection results in enforcement action, you shouldn't have to scramble for legal representation. ADF's legal defense coverage provides included attorney hours through our partner regulatory law firms — specialists in FDA enforcement, warning letters, and consent decree negotiations.
Coverage is conditional on maintaining your compliance program — because proactive defense starts with preparation.
Schedule a free discovery call and we'll walk you through exactly how ADF protects your brand while improving efficiency.