What is a Polymath?
Pol-ee-math (noun): An individual whose knowledge spans a substantial number of subjects, known to draw on complex bodies of knowledge to solve specific problems.
OUR SIZE IS OUR STRENGTH
About Us
Polymath provides holistic quality and quality compliance solutions to life sciences/pharmaceutical companies and a myriad of other industries. As a boutique firm, we don’t compete with big, corporate consulting firms because our size is our strength! Our consultants are a select group of professionals, many having multiple graduate degrees (e.g., law degrees and Ph.D.s in STEM fields) and varied professional work experience (e.g., ex-FDA and Big Pharma).
Our size and selectivity allow us to provide the best possible outcomes for our clients at lower costs.
We utilize technical subject matter expertise, knowledge of U.S. and international laws and regulations, and FDA and industry experience to provide our clients with exceptional advisement. Whether we are supporting single or complex multi-Health Authority inspections, conducting internal company audits, designing and/or assisting in GMP training or learning and development, providing Quality Management System (QMS) services or advising on complex compliance matters, our goal is to minimize risk to our clients.
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.
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.
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.