About AP FDA Consulting
Let us help you turn your next FDA inspection from a source of anxiety into a demonstration of excellence.
The Elite Insider Perspective on Compliance
In the high-stakes world of life sciences, the difference between a successful inspection and a devastating FDA Warning Letter often comes down to one thing: preparation. At AP FDA Consulting, we provide that preparation through the eyes of the agency itself.
Headquartered in California, we are a premier regulatory consulting firm with a global reach. While our roots are in the United States, we travel the world to ensure that manufacturers are ready for the rigor of an official FDA audit. With strategic hubs in San Francisco, Europe, and Seoul, we bridge the gap between local operations and international regulatory expectations.
Who Understands the FDA Better Than Those Who Ran the Inspections?
Who else understands your situation better than those who did the heavy work in the FDA investigation and compliance? Our team is composed exclusively of:
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Former FDA Investigators: Experts who have walked thousands of facility floors and issued numerous Form 483s. They know exactly where systems break down under pressure.
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Former FDA Compliance Officers: The decision-makers who reviewed inspection reports and issued numerous FDA Warning Letters. They understand the legal threshold for enforcement action.
We Value Proposition: Elite Authority at Reasonable Costs
The industry has long been dominated by the “Big 4” and large global consulting conglomerates.
The Reality of the Market: While large ‘Big 4’ consulting firms charge premium rates to cover massive corporate overhead, FDAAPC provides direct access to Ex-FDA expertise without the unnecessary bloat. We offer the most cost-effective and reasonable cost mock audits in the industry.
By streamlining our operations, we ensure your budget goes directly toward the expert’s time and knowledge. Every life science company—from a San Francisco biotech startup to a European pharmaceutical giant—deserves access to the best possible advice without paying for a consultant’s marketing budget.
Targeted Expertise Across the Life Science Spectrum
We provide specialized mock FDA inspections tailored to the specific 21 CFR requirements of your industry. Whether you are a startup in California or a global manufacturer in Switzerland or Korea, we apply the exact regulatory lens the FDA will use.
Pharmaceutical Manufacturers (21 CFR Part 210 & 211)
For drug manufacturers, the stakes of cGMP (Current Good Manufacturing Practice) are absolute. Our Ex-FDA team performs deep-dive audits into 21 CFR Part 210 (General) and 21 CFR Part 211 (Finished Pharmaceuticals). We focus on data integrity, laboratory controls, and contamination prevention—the primary drivers of modern Warning Letters.
Medical Device Manufacturers (21 CFR Part 820)
Device firms must navigate the complexities of the Quality Management System Regulation (QMSR). We audit against 21 CFR Part 820, focusing on Design Controls, CAPA (Corrective and Preventive Actions), and P&PC (Production and Process Controls). As the FDA transitions toward ISO 13485:2016 alignment via the Quality Management System Regulation (QMSR), our former investigators ensure your transition is seamless.
Combination Products (21 CFR Part 4)
Products that combine drugs, devices, or biological products face a “dual-threat” regulatory landscape. We specialize in the “streamlined” quality system requirements under 21 CFR Part 4, ensuring that both the drug and device components meet their respective primary mode of action (PMOA) requirements.
In Vitro Diagnostics (IVD) & Companion Diagnostics (CDx/PDx)
The diagnostic sector faces unique challenges in validation and clinical performance. We audit IVD and Companion Diagnostic (CDx/PDx) manufacturers under the applicable sections of 21 CFR Part 820, 21 CFR Part 212, and 21 CFR Part 809, ensuring that analytical and clinical validity data meet the agency’s stringent requirements for patient safety and diagnostic accuracy.
Global Reach: Based in California, Active Worldwide
While we are proudly based in California, our mission is global. The FDA’s reach is international, and so is ours. A manufacturing site in Seoul or a clinical research organization in Zurich faces unique cultural and logistical challenges when preparing for a U.S. FDA visit.
Our investigators travel to every corner of the globe to provide onsite, “boots-on-the-ground” mock inspections. We bring the authentic atmosphere of a real FDA visit to your facility, ensuring that your staff is coached on the tactical aspects of an inspection—from “Front Room” management to “Back Room” technical defense.
OUR PRINCIPAL FDA CONSULTANT
EXPERIENCES
- Independent Quality and Regulatory Auditor
- Mock FDA Inspections
- CAPA Mediation Expert
- Gap Assessment Analysis
- Former Supervisory Investigator, U.S. FDA Office Of Regulatory Affairs
- District Medical Devices Program Monitor
- International Inspection Cadre – Medical Device Group
- Compliance Officer, FDA Office Of Regulatory Affairs
- Investigator, FDA Office Of Regulatory Affairs
- Chemist, FDA Office Of Regulatory Affairs
- FDA Investigator Performance Auditor Certification
- FDA Investigator Certification
While at the FDA, our Principal Consultant served as a national expert in the laws and regulations governing unapproved new drugs. As a former FDA Compliance Officer, he reviewed and approved or disapproved Warning Letters, seizures, and injunctions. As such, he has extensive knowledge of 21 USC when taking action against unsafe products in the U.S. market. Furthermore, he reviewed product labels and ensured that the information was truthful and not misleading.
As a former FDA Investigator, our FDA consultant performed establishment inspections from the simple to the most complex type.
In addition, he issued numerous FDA Form 483, Inspectional Observations, to the firms violating the FD&C Act and the Code of Federal Regulations Title 21 (21 CFR) that require firms to adhere to the Quality Management System Regulation (QMSR). Also, he collected numerous documentary samples to establish FDA jurisdiction for required legal intervention by the FDA. Contact us to schedule mock FDA inspections by a former United States Food and Drug Administration Field Office Investigator.
Why Our Principal FDA Consultant
Finding an ex-FDA inspector for your FDA consulting is crucial for pharmaceutical and medical device manufacturers. Actually, we can help manufacturers meet their most challenging roles—complying with US FDA laws and regulations.
We have helped numerous manufacturers with diverse scenarios.
At AP FDA Consulting, we are passionate about making a difference, and this passion is one of the core features that keep us highly motivated in our mission of providing FDA consulting. Our ex-FDA inspectors assist in preparing for FDA inspections while following the latest FDA guidelines for evaluating your quality system.
Contact us to schedule
Contact us to get started with our well-qualified FDA consultant. Also, our availability is limited.
Our Methodology: The “simulation of FDA Inspection” Mock Inspection
Because our team consists of Former FDA Investigators, we replicate the agency’s specific audit techniques to identify risks before the official investigator arrives.
- Form 483 Risk Identification: We identify 483-level observations in real-time. By the time we leave your facility, you will have a prioritized list of findings that look exactly like what an investigator would write.
- Warning Letter Prevention: Our Former FDA Compliance Officers review your mock audit findings to assess your “Warning Letter Risk.” This high-level perspective allows executive leadership to understand the potential business impact of non-compliance.
- Pressure Testing: We don’t just review documents; we interview subject matter experts (SMEs) to ensure they can defend their processes under the intense questioning typical of an FDA inspection.