Will you be ready when the government knocks?

Inspection Support

Services Include

  • Modern Inspection Support
  • Inspection Readiness
  • Inspection Remediation

 

Modern Inspection Tools

We use cutting-edge industry tools and subject matter expertise to help you remain compliant.

We are dedicated to empowering FDA-regulated businesses to achieve their quality and compliance goals. With a team of former FDA investigators and a wealth of industry experience, we offer tailored inspection solutions. Whether support is needed before, during or after the inspection, our experts are available!

We believe in a client-centric approach, tailoring our services to meet the unique needs and objectives of each organization. Polymath consultants work closely with clients to understand their challenges, develop strategic roadmaps, and execute effective solutions.

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Strategic Planning

Flexible logistics plans

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Inspection Intelligence

Use of industry and Agency trends and inspector intelligence reports

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Mock Inspections

Former FDA investigators identify potential observations before the Agency

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Training & Coaching

Training and teaching professionals coach and challenge subject matter experts

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Effectiveness Checks

Verify and confirm effectiveness of corrective and preventive actions prior to inspection

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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/with very little prior notice. All companies that are subject to GMP regulations should remain in a permanent state of 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.

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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.

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Competent & Confident SMEs

Confident SMEs who are well-trained on company procedures and their job duties, able to effectively communicate, not easily flustered or aggressive when challenged.

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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.

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Ability to Cover Difficult Topics

SMEs must be well-prepared to speak to complex quality events (e.g., deviations, out-of-specifications (OOS)). Storyboard formulation and the introduction of cross-functional teams may be needed.

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Mock Inspections

Internal audits are a part of every mature quality system, but few internal auditors have the training of Health Authority inspectors. Our exFDA inspectors mimic actual FDA inspections, potentially identifying 483 observations before an inspection.

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.

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Whether your inspection is a general GMP, surveillance inspection or a more focused inspection like a pre-approval or for-cause inspection, our consultants have experience in response writing.  Our experts includes is responding to Form FDA 483, Warning Letters,  and Non-compliance reports.
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Avoid the frustration and unnecessary rounds of review by Health Authorities and let us help you ensure your response and corrective and preventative actions (CAPAs) are right the first time!
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We will also assist you with formulating compliant, cost-effective CAPAs as well as conduct CAPA verification and effectiveness checks, preventing repeat observations.
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We also offer project management services to ensure you meet timelines and do not waste resources on inefficient processes. 

TESTIMONIALS

Our Clients & Partners Speak

Jared Clark
President/Owner Certify Consulting Group
Stephen H. Bryant, Jr.
VP Quality & Reg Affairs TAKA USA, INC.
Dr. David Glover
Owner EAA Quality Food Solutions LLC

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
Over-the-Counter (OTC) Drugs
Cosmetics & Cosmetic Ingredients
Personal Care Products
IOS Certified Products

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.

 

IOS 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.