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 use cutting-edge industry tools and subject matter expertise to ensure that your business remains compliant. We collaborate with Atlas-Compliance, the premier FDA inspection platform for insights and research, to bring cutting-edge artificial intelligence services to our clients. This partnership means that we can generate inspector intelligence reports, access FDA inspectional trends, and research any question posed during an inspection using a database of over 25,000 FDA 483s as well as establishment inspection reports (EIR), Warning Letters, guidance documents and other data.
Through these and other tools, we empower FDA-regulated companies to achieve their quality and compliance goals. With a team of former FDA investigators and a wealth of industry experience, we tailor our inspection solutions to meet your specific needs. We work closely with our clients to understand their challenges, develop strategic roadmaps, and execute effective solutions.
Whether support is needed before, during or after the inspection, our experts are available! We also offer on-site and remote options.
Strategic Planning
Flexible logistics plans
Inspection Intelligence
Use of 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
Verifying and confirming effectiveness of corrective and preventive actions prior to inspection
Report 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
Inspection tour routes, designated functional rooms with adequate staffing, mechanisms for fielding documentation requests in various media (e.g., USB drives, online platforms) etc.
Competent & Confident SMEs
Inspection SMEs are those who are well-trained on company procedures and job duties, able to effectively communicate, not easily flustered or aggressive when challenged.
Knowledge of Current Health Authority Expectations
Health Authorities update and publish new regulations and guidance documents that companies may not be aware of or have not incorporated 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 part of every mature 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 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 SIZE IS OUR STRENGTH
Our Commodities Expertise
Prescription (Rx) Drugs
We offer quality and GMP solutions for all types of prescription drugs including biologics (large molecules) small molecules, and APIs. We have expertise in sterile injectables, solid oral dosages, ophthalmic, dermatologic etc.
Over-the-Counter (OTC) Drugs
We offer quality and GMP solutions for OTC medicines including upper respiratory remedies, oral analgesics, heartburn treatments, antiperspirants, toothpaste, sun protection, laxatives, first aid, hand sanitizers etc.
Cosmetics & Cosmetic Ingredients
We offer quality and GMP solutions for cosmetic ingredients, skin and haircare, make-up etc.
Personal Care Products
We offer quality and regulatory solutions for creams, hair dyes, bath soaps, shampoos etc.
ISO Certified Products
We offer quality solutions for ISO certified facilities/products, e.g., wipers for pharmaceutical purposes, raw ingredients for use in various commodities.
Dr. Constance Y. Fears
Meet Our Founder & Principal Polymath
Constance brings almost two decades of technical, legal, and life sciences/pharmaceutical manufacturing experience to Polymath. She holds a Ph.D. in Cellular and Molecular Biology, Juris Doctor (J.D. - 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, FDA Certified Drug Investigator/Inspector, and Associate Director of Quality Assurance 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.