preferred choice among consultants
Global Quality & Regulatory Compliance Experts
We are former FDA investigators with expertise in Quality Assurance & Quality Control, Complex Quality Compliance Matters, Audits, Quality Management Systems (QMS), Training and Learning & Development, and Inspection Support including inspection readiness, FDA 483 and Warning Letter Remediation.
We specialize in prescription, compounded and over-the-counter (OTC) drugs, cosmetics, cosmetic ingredients, personal care products and ISO certified products.
CUT OUT THE MIDDLE MAN
We’re the experts that big corporate consulting firms call!
Hiring a consultant isn’t cheap! Did you know that a large percentage of corporate consultants are independent contractors, and that some consultant firms charge their clients TEN TIMES what they pay the contractor who actually performs the service? Get the same expert consultant without the middle man and high price tag!
Our highly-personalized strategy ensures that you are not bogged down with corporate red tape or generic solutioning that does not align with your specific needs or risk posture.
Beyond consultancy, we are dedicated to your success. Our partnership doesn’t end with lengthy audit reports or a litany of action items. We work hand-in-hand with you to implement compliant strategies that yield measurable outcomes and a lasting impact.
Personalized Services That Fit Your Needs
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.
Global Regulatory Expertise
Navigating Health Authority Requirements Worldwide
US FDA - ANVISA - ANMAT - COFEPRIS - NMPA - MFDS - EMA - Health Canada - WHO - ISO - MHRA - PMDA - PIC/S - HPRA - EFfCI
At Polymath, our expertise extends far beyond U.S. borders. We have in-depth knowledge of international health authorities, enabling us to guide you through compliance with global regulations. From Europe to Asia, we ensure your products meet the strict standards of every major market, keeping your business compliant and competitive on a global scale.
OUR SIZE IS OUR STRENGTH
Our Business Model
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.
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.
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. 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!
Your Success is
Our Mission
our founder
Dr. Constance Y. Fears
Dr. Fears brings 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.
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.
Empower. Educate. Excel.
Our Learning Community
Join our Learning Community on YouTube, where industry experts share essential tips, tricks, and insights to help you navigate the complexities of quality and compliance in life sciences, pharmaceuticals, and beyond. Empower your journey with knowledge in every video!
Foreign Inspection Tips
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FDA Inspection Tips
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