preferred choice among consultants

Global Quality & Regulatory Compliance Experts

We are former FDA investigators with expertise in Audits, Quality Assurance & Quality Control, Complex Compliance Matters, 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 MIDDLEMAN

We’re the experts that big corporate consulting firms call!

Hiring a consultant is not cheap!  Did you know that a large percentage of corporate consultants are actually independent contractors, and that some consultant firms charge their clients TEN TIMES what they pay the contractor who performs the service?  Get the same expert consultant without the middleman 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 does not 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.

Our Commodities Expertise

Prescription Drugs
Over-the-Counter Drugs
Compounded Drugs
Cosmetics & Cosmetic Ingredients
Personal Care Products
ISO Certified Products

Prescription 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 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.

 

Compounded Drugs

We offer quality and GMP solutions for compounded drugs in all forms including, oral dosages and injectables. We realize that compounded drugs provide major cost savings to customers and healthcare partners. Let us keep your operations compliant with federal laws and regulations.

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 products, including finished goods and raw materials for use in various industries.

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 and 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

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

Dr. Constance Y. Fears

Dr. 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 (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

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.

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!

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