Global Quality and GMP Compliance Experts
US FDA - ANVISA - ANMAT - COFEPRIS - NMPA - MFDS - EMA - Health Canada - WHO - ISO - MHRA - PMDA - PIC/S - HPRA - EFfCI
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US FDA - ANVISA - ANMAT - COFEPRIS - NMPA - MFDS - EMA - Health Canada - WHO - ISO - MHRA - PMDA - PIC/S - HPRA - EFfCI -
We are ExFDA consultants with expertise in Quality Assurance, Complex Compliance Matters, CGMP Audits, Inspection Support, Inspection & Warning Letter Remediation, Quality Management Systems (QMS) and Learning & Development. We specialize in prescription and over-the-counter (OTC) drugs, cosmetics, cosmetic ingredients, personal care products and ISO certified products.
Our Business Model
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Breadth and Depth of Expertise
Our consultants have both FDA and industry experience in quality matters (e.g., quality assurance, quality control, QMS) and experience in GMP regulation and compliance (e.g., global inspections and audits). We bring knowledge of international laws and regulations, combined with an understanding of local legal nuances. Our consultants have diverse educational/technical backgrounds, including advanced degrees, e.g., Ph.D., and specialized knowledge, e.g., cannabis-based technology.
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Affordable Custom Solutions
One size doesn't fit all. We understand the uniqueness of your quality and GMP challenges. Our consultants work collaboratively with you to tailor solutions that align with your specific goals. Our highly-personalized, one-to-one strategy ensures that you are not bogged down with corporate consulting red tape or generic solutioning that does not align with your needs or risk posture. Also, our boutique size allows us to offer second-to-none service at a fraction of the cost of large corporate consulting firms. Our size is our strength!
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Your Success is Our Mission
Beyond consultancy, we are dedicated to your success. Our partnership doesn’t end with lengthy audit reports or a litany of recommendations. We work hand-in-hand with you to implement GMP-compliant strategies that yield measurable outcomes and a lasting impact.
Our Founder
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Dr. Constance Y. Fears
FOUNDER & PRINCIPAL CONSULTANT
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Education and Experience
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, U.S. FDA Certified Drug Inspector, 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.
Our Clients
We provide quality and regulatory compliance consulting services to drug/healthcare and cosmetic companies, contract manufacturing organizations, consulting firms, software companies specializing in artificial intelligence and IT solutions, and educational institutions.
Our Services
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We provide assistance after receipt of an unfavorable inspection outcome, e.g., FDA 483, Warning Letter, Non-compliance Report. Let our expertise in response writing, regulatory meeting advocacy, remediation audits, and CAPA implementation, help you in achieving a speedy resolution!
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We provide on-site and virtual technical and regulatory support before and during an inspection. Let our expertise in performing mock FDA inspections, employee coaching, inspection logistics (e.g., backroom organization), storyboard development, and strategizing to answer the tough questions, make your next inspection your best!
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We perform audits of drug manufacturers (API and finished dose), QC laboratories, (re)packagers & (re)labelers and raw material/component suppliers in accordance with applicable regulations (e.g., CGMP) and standards (e.g., ISO-9001). Let our exFDA inspectors and exBigPharma auditors perform your next third party audit!
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We author and review QMS documents including standard operating procedures (SOPs), quality policies and standards, work instructions and job aids, ensuring that they are fit for purpose and aligned with applicable regulations (e.g., CGMPs), standards (e.g., ISO-9001) and industry best practices. Let us design and modernize your QMS!
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We design and instruct quality (e.g., data integrity) and annual CGMP training. Let us design your next annual GMP training course!
We also develop and provide instruction at the undergraduate and graduate level in biotechnology, Quality and GMPs, and Regulatory Affairs. Let us design and teach your next university course!
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We use our technical and regulatory knowledge to research and answer complex quality and compliance questions, e.g., foreign regulations, industry best practices, sterility issues. Let us assist with questions or issues that require specialized research or additional expertise!
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We provide quality, GMP and inspectional expertise to companies developing software solutions for life sciences and pharmaceutical companies. Our subject matter experts will ensure that your software and platform meets the needs of the end user!
Our Commodities Expertise
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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. See “Our Services”.
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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. See “Our Services”.
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We offer quality and GMP solutions for cosmetic ingredients, skin and haircare, make-up etc. See “Our Services”.
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We offer quality and regulatory solutions for creams, hair dyes, bath soaps, shampoos etc. See “Our Services”.
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We offer quality solutions for ISO certified facilities/products, e.g., wipers for pharmaceutical purposes, raw ingredients for use in various commodities. See “Our Services”.
Our Clients & Partners Speak
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"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."
Jared Clark, President/Owner Certify Consulting Group
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“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!”
Stephen H. Bryant, Jr., VP Quality & Reg Affairs TAKA USA, INC.
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“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.”
Dr. David Glover, Owner EAA Quality Food Solutions LLC
Our Learning Community
The Polymath Reg Consultants YouTube channel is coming soon! Our first course is FDA Inspections 101. Get the basics on US FDA inspections including resources used by the Agency during inspections, most cited observations, strategizing for difficult topics, and much more! Sign up with your email below to receive notifications of when the course is uploaded.