Quality and Compliance Advisement

Polymath specializes in helping clients solve Quality and Compliance issues that may veer outside of the everyday concerns. These may include complex matters related to recalls, understanding a regulation or guidance, submitting supplemental documentation to Health Authorities etc.

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Advisement on Complex Quality and GMP Issues

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Understanding and Interpreting Regulations

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Understanding New Guidance Documents

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Health Authority Trending and Data Analysis

You’ve Got Questions, and We’ve Got Answers.

We’ve partnered with Atlas-Compliance to provide artificial intelligence solutions and custom data analytics reports, e.g., supplier/contractor compliance comparisons, heat maps and forecasting.

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.

OUR SIZE IS OUR STRENGTH

Our Commodities Expertise

Prescription (Rx) Drugs
Over-the-Counter (OTC) Drugs
Cosmetics & Cosmetic Ingredients
Personal Care Products
IOS Certified Products

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.

 

IOS Certified Products

We offer quality solutions for ISO certified facilities/products, e.g., wipers for pharmaceutical purposes, raw ingredients for use in various commodities.

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.