the preferred choice among consultants
Global Quality & Regulatory Compliance Experts
We are former FDA investigators and ISO-certified professionals with expertise in Audits, Quality Assurance & Quality Control, Quality Management Systems (QMS), Training and Learning & Development, Health Authority Inspection Support.
We serve all manufacturing sectors, specializing in drugs, food & beverages, medical devices, cosmetics, personal care products, cannabis, and ISO-certified products (e.g., defense, automotive, paper-based products).
Our clients include small and mid-size companies, some of the world’s largest innovation companies and CMOs/CDMOs, startups, corporate consultancies and more!
not your ordinary consultants
There are many consultants but few Polymaths.
Hiring the right consultant can be stressful, but Polymath will put you at ease with our subject matter experts, simplified processes and transparent pricing. Our consultants include former FDA inspectors, ISO-certified auditors and professionals from across varied industries with decades of experience. Many Polymath consultants have advanced degrees in a variety of disciplines (e.g., chemistry, law, business) allowing us to protect your products by understanding the applicable technology and legal requirements. Say goodbye to generic solutioning and let the depth and breadth of our knowledge curate custom solutions to protect your brand and customers.
Personalized Services That Fit Your Needs
We offer a range of services to ensure you remain compliant.
Our Product Expertise
Prescription and OTC
We offer GLP, GCP and GMP solutions for all types of drugs including biologics and vaccines, small molecules, APIs and drug substances. We have expertise in sterile injectables, solid oral dosages, ophthalmic, topicals etc. Our service offerings also apply to laboratory operations, product storage and distribution of drugs.
Medical Devices
We offer quality and GMP solutions for Class I, II, and III medical devices. See our service offerings.
Cosmetics & Cosmetic Ingredients
We offer quality and GMP solutions for Cosmetics and Cosmetic Ingredients. See our service offerings.
Food, Supplements & Beverages
We offer quality and GMP solutions for foods, dietary supplements and beverages. See our service offerings.
ISO-Certified Products
We offer quality and regulatory solutions for ISO-certified products, which can range from raw materials, defense, paper products, flooring, and other non-FDA regulated products. See our service offerings.
Choose Your Polymath by Product or Service
- W. Carter, MS
- T. Harris, MS, CQA
- J. Eckenfels, MS (more info to come)
- D. Glover, PhD (more information to come)
- T. Harris, MS, CQA
- W. Carter, MS
- K. Dobbin, MPH
- C. Fears, JD, PhD
- J. Eckenfels, MS (more info to come)
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 and more!
At Polymath, our expertise extends far beyond US 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, globally.
OUR DIVERSE EXPERTISE IS OUR STRENGTH
Our Business Model
We bring knowledge of US and international laws and regulations, combined with an understanding of industry-specific nuances. Our consultants have diverse educational, technical and professional backgrounds, including advanced degrees and specialized subject matter expertise.
Breadth and Depth of Expertise
Our consultants possess legal, regulatory and technical expertise. Thus, we provide our clients with a breadth and depth of knowledge for holistic solutions.
Affordable Custom
Solutions
Our consultants work collaboratively with clients to tailor solutions that align with your goals and risk posture, offering customer-centric services at competitive rates.
Your Success is
Our Mission
We are dedicated to your success! We work hand-in-hand with our clients to implement 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 (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.
Empower. Educate. Excel.
Our Learning Community
Join our Learning Community on YouTube, where we share essential tips 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!
Click here to view our YouTube channel!
FDA Inspection Tips
Increase your inspection readiness in less than 5 minutes with our FDA inspection tips!
Learn More
Foreign Inspection Tips
Increase your inspection readiness in less than 5 minutes with our foreign inspection tips!
Learn More
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.