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.
We know how to prevent and remediate FDA 483s, Warning Letters and Untitled Letters because we’ve issued them! Let our former FDA inspectors advise you throughout the inspection process, from pre-inspection preparation to post-inspection remediation.
In addition to FDA experience, many of our consultants possess graduate degrees in STEM disciplines such as molecular biology, microbiology and chemistry, giving us the technical and regulatory expertise to provide holistic solutions. We have also partnered with the premier FDA inspection platform, Atlas-Compliance, allowing us to provide our clients with cutting-edge inspectional intelligence, including access to the largest database of FDA 483s, access to Warning Letters and establishment inspection reports (EIR), FDA trends, predictive Inspector Intelligence Reports, which use trending data and Artificial Intelligence (AI) to accurately pinpoint an inspector’s likely areas of focus during an inspection.
Through our FDA experience, technological tools and many other resources, we empower FDA-regulated companies to achieve their quality and compliance goals. We tailor our inspection solutions to meet your specific needs by working closely with you to understand your challenges, develop strategic roadmaps, and execute effective solutions.
Our experts are always available to provide on-site and remote options.
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!
Many Health Authorities have the legal right to inspect your facility without or with very little prior notice. All companies that are subject to GMP regulations should remain in a permanent state of inspection readiness.
Permanent inspection readiness (PIR) is NOT a state of perfection, but an ongoing, proactive process based on Health Authority intelligence and proven strategies shown to yield better inspectional outcomes across regulated industries. Some features of a mature PIR plan include.
A Flexible Logistics Plan
Pre-planned inspectional tour routes, designated functional rooms with adequate staffing, efficient mechanisms for fielding documentation requests in various media (e.g., USB drives, online platforms)
Competent & Confident SMEs
Inspection SMEs are those who are well-trained on company procedures and job duties and able to effectively communicate without becoming easily flustered or aggressive when challenged.
Knowledge of Current Health Authority Expectations
Our experts remain current on new Health Authority regulations and guidance documents that companies may not be aware of or have yet to incorporate into their QMS.
Ability to Cover Difficult Topics
SMEs must be well-prepared to speak to complex quality events (e.g., deviations, out-of-specifications). Storyboard formulation and the introduction of cross-functional teams may be needed.
Mock Inspections
Internal audits are a necessary part of every quality system, but few internal auditors have the training of Health Authority inspectors. Our former FDA inspectors mimic actual FDA inspections, identifying potential 483 observations before an inspection, allowing for remediation in advance of Agency arrival.
Inspection Remediation
Correct it right. Correct it once.
Let Polymath assist you with responding to a Health Authority after an inspection. Our experience is global, covering the US FDA, EMA, local/regional Health Authorities, and multi-agency inspections.
We also offer project management services to ensure you meet timelines and do not waste resources on inefficient processes.
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.