Will you be ready when the government knocks?
Inspection Support
Services Include
- Modern Inspection Support
- Inspection Readiness
- Inspection Remediation
Modern Inspection Support
Strategic. Efficient. Effective.
Our perspective is singular: we understand how FDA Form 483 observations, Warning
Letters, and Untitled Letters are issued—because we have issued them. This firsthand experience allows our former FDA inspectors to guide you with precision and discretion across the entire inspection lifecycle, from refined pre-inspection readiness through seamless post-inspection remediation.
Our advisory is further distinguished by deep scientific fluency. Many of our consultants hold
advanced degrees in disciplines such as molecular biology, microbiology, and chemistry,
enabling us to deliver solutions that are as technically rigorous as they are regulatorily sound.
We elevate this expertise through our partnership with Atlas Compliance, a premier FDA
inspection intelligence platform. This collaboration provides curated access to expansive
datasets—including FDA 483 observations, Warning Letters, and Establishment Inspection
Reports—alongside sophisticated trend analyses and predictive Inspector Intelligence Reports.
Powered by advanced analytics and artificial intelligence, these insights anticipate areas of
regulatory focus with notable accuracy.
The result is a highly tailored, concierge-level approach to compliance. We work in close
alignment with your organization to understand its nuances, design strategic pathways, and
execute with clarity and confidence—ensuring enduring quality and regulatory excellence.
Our experts remain readily available to support your needs through both discreet on-site
engagements and seamless remote advisory.
Strategic Planning
Flexible logistics plans
Inspection Intelligence
Industry and Agency trends and inspector intelligence reports
Mock Inspections
Former FDA investigators identify potential observations before the Agency
Training & Coaching
Training and teaching professionals, coaching and challenging subject matter experts
Effectiveness Checks
Verification and confirmation of effectiveness of corrective and preventive actions prior to inspection
Response writing
Expert assistance in responding to FDA 483, Warning Letters, Non-compliance reports etc.
Inspection Readiness
If you stay inspection ready, you don’t have to get ready!
Health Authorities retain the authority to conduct inspections with little to no advance
notice. For organizations operating under GMP regulations, this necessitates a continuous state of readiness—one that is embedded, not episodic.
Permanent Inspection Readiness (PIR) is not the pursuit of perfection, but the cultivation of a
disciplined, anticipatory posture. Informed by Health Authority intelligence and refined through proven methodologies, a mature PIR program enables consistently favorable inspection outcomes. Its hallmarks include:
A Flexible Logistics Plan
Thoughtfully designed inspection pathways, dedicated functional spaces supported by appropriate personnel, and seamless systems for responding to documentation requests across both digital and physical formats.
Competent & Confident SMEs
SMEs who possess a deep command of their responsibilities and communicate with clarity, composure, and credibility—particularly under regulatory scrutiny.
Knowledge of Current Health Authority Expectations
A deliberate commitment to remaining current with emerging regulations and guidance, ensuring that the quality management system reflects the latest regulatory standards.
Ability to Cover Difficult Topics
The ability to articulate nuanced quality events—such as deviations and out-of-specification results—with precision and confidence, often supported by structured narratives and cross-functional alignment.
Mock Inspections
While internal audits are foundational, they seldom replicate the rigor of regulatory review. Mock inspections conducted by former FDA inspectors are designed to mirror actual inspection
conditions, identifying potential observations in advance and enabling thoughtful, timely remediation prior to Agency engagement.
Inspection Remediation
Correct it right. Correct it once.
Entrust Polymath to guide your organization through Health Authority responses with
precision and confidence following an inspection. Our perspective is global, with deep
experience across the U.S. FDA, EMA, regional authorities, and complex multi-agency
engagements.
Whether addressing routine GMP inspections, surveillance activities, pre-approval reviews, or for-cause investigations, our consultants craft clear, strategic, and regulator-ready responses. We provide expert support in addressing FDA Form 483 observations, Warning Letters, and non-compliance findings with clarity and authority.
We mitigate the inefficiencies of prolonged regulatory back-and-forth by ensuring your responses—and associated CAPAs—are comprehensive, well-substantiated, and aligned with
Health Authority expectations from the outset.
Our team develops compliant, pragmatic, and cost-conscious CAPAs tailored to your organization. We further support verification and effectiveness evaluations to ensure sustainable
resolution and prevent recurrence.
Through discreet and disciplined project management, we ensure adherence to critical timelines, optimize resource deployment, and deliver a streamlined, efficient remediation process.
TESTIMONIALS
Our Clients & Partners Speak
My Preferred Choice!
Constance stands out as my preferred choice among ex-FDA consultants. Her approachable, down-to-earth demeanor makes communication effortless, fostering a collaborative working environment I highly value. Her expertise was pivotal in guiding my client through their remediation efforts, further solidifying my confidence in her abilities. Given her exceptional skills and easy rapport, I find it hard to consider partnering with anyone else.
Makes Auditing Work Fun!
Constance conducts cGMP audits in a very professional, fair manner and is extremely knowledgeable of FDA regulations and requirements. She possesses excellent communication, teaching and personable relationship skills and is very easy with which to work. She really makes auditing work fun!
One of the most knowledgeable individuals I have had the pleasure of knowing.
Having worked with Dr. Fears in academic research, federal regulatory and industrial manufacturing settings, she is one of the most knowledgeable individuals I have had the pleasure of knowing. She brings vast technical and regulatory expertise from her time in academia, the FDA and pharmaceutical industry. You can definitely trust that she is capable and driven to deliver the best possible outcome.
Our Product Expertise
Prescription and OTC
We offer GLP, GCP and GMP solutions for all types of drugs including biologics and vaccines, small molecules, APIs and drug substances. We have expertise in sterile injectables, solid oral dosages, ophthalmic, topicals etc. Our service offerings also apply to laboratory operations, product storage and distribution of drugs.
Medical Devices
We offer quality and GMP solutions for Class I, II, and III medical devices. See our service offerings.
Cosmetics & Cosmetic Ingredients
We offer quality and GMP solutions for Cosmetics and Cosmetic Ingredients. See our service offerings.
Food, Supplements & Beverages
We offer quality and GMP solutions for foods, dietary supplements and beverages. See our service offerings.
ISO-Certified Products
We offer quality and regulatory solutions for ISO-certified products, which can range from raw materials, defense, paper products, flooring, and other non-FDA regulated products. See our service offerings.
Dr. Constance Y. Fears
Meet Our Founder & Principal Polymath
Constance Fears brings two decades of technical, legal, and pharmaceutical manufacturing experience to Polymath. She holds a Ph.D. in Cellular and Molecular Biology, Juris Doctor (law, regulatory law), and graduate diploma in International and French Law. Drawing on her diverse educational background, she has held various positions including, molecular biology post-doctoral research fellow, tenure-track university professor, US FDA Certified Drug Investigator and Director of Quality Systems & Compliance at one of the world’s largest pharmaceutical companies. Combining formal education and professional experience, she offers a broad perspective to solve complex quality and compliance issues as a technical and regulatory expert.