A straightforward onboarding process that gets you inspection-ready without disrupting your operations. No lengthy IT implementations. No months of setup. Just a clear path to compliance.
We learn about your facility, products, and compliance needs.
Day 1Thorough gap analysis with risk scoring and remediation plan.
Days 2 – 14Your customized Audit Defense Playbook, ready for inspections.
Days 15 – 25Quarterly reviews, mock inspections, and on-demand support.
Day 30+Every engagement begins with a 30-minute discovery call. This is where we learn about your business, your facility, your products, your regulatory history, and your current compliance posture. We ask the right questions so we can design a program that fits your operation — not a one-size-fits-all template.
By the end of the call, you'll have a clear understanding of what ADF does, how it works, and whether we're the right fit. There's no pressure and no obligation.
Once you're onboard, our compliance team conducts a comprehensive review of your entire quality and compliance infrastructure. We examine documentation, SOPs, training records, facility practices, CAPA systems, supplier qualifications, and quality system procedures.
The output is a detailed compliance risk score, a gap analysis mapped to current FDA expectations for your specific industry, and a prioritized remediation roadmap with clear timelines and accountability assignments. This becomes the foundation for your entire ADF program.
Your customized Audit Defense Playbook is a comprehensive, inspection-ready binder that consolidates everything your team needs when the FDA shows up. It includes procedures for greeting inspectors, managing document requests, handling observations, and escalation protocols.
The Playbook is tailored to your specific facility, your products, and your regulatory classification. It's not a generic template — it's built from the findings of your baseline assessment and reflects your actual compliance posture and procedures.
This is where ADF is fundamentally different from project-based consulting. Once your baseline is established and your Playbook is delivered, we don't disappear. Your compliance program continues with quarterly reviews, on-demand expert support, and scheduled mock inspections.
Quarterly reviews catch compliance drift before it becomes an audit finding. On-demand support means you have a compliance expert to call whenever a question arises — a process change, a supplier issue, a labeling question. And mock inspections keep your team sharp and your facility ready.
Our onboarding process was designed to minimize disruption while maximizing your compliance posture from day one.
Unlike enterprise QMS platforms that take 6–12 months to deploy, ADF gets you covered in 30 days. No IT projects, no software rollouts, no change management headaches.
Compliance gaps reopen without ongoing monitoring. ADF's quarterly reviews and on-demand support ensure you never drift back into non-compliance after the initial assessment.
Your compliance program is managed by experienced professionals — former FDA investigators and QA/RA experts — not a dashboard you have to learn and manage yourself.
Schedule a free 30-minute discovery call. We'll assess your compliance posture and recommend the right plan for your facility.