Ensure Your QMS is Current and Compliant
Quality Management Systems
Product quality is not merely a commercial expectation—it is a defined legal obligation at both state and federal levels, irrespective of the product offered for sale.
Within the United States, the Uniform Commercial Code (UCC), together with corresponding
state commercial statutes such as the Georgia Code, establishes both express and implied
warranties governing goods placed into the marketplace. In essence, products must conform to their stated description, meet acceptable standards of quality, and perform as intended.
In regulated sectors—including pharmaceuticals, medical devices, chemicals, cosmetics, food,
and automotive manufacturing—additional federal requirements further define and elevate
expectations for product quality. In many of these industries, formal Quality Management
Systems (QMS) are not optional; they are contractual obligations and widely recognized industry standards. Accordingly, the establishment, maintenance, and periodic evaluation of a QMS is fundamental to sustaining both regulatory compliance and customer confidence.
Within FDA-regulated environments, deficiencies in procedural documentation remain among
the most frequently cited observations in FDA Form 483 inspections. Polymath consultants bring extensive experience in authoring and refining QMS frameworks for globally distributed
products, as well as ensuring alignment with multi-jurisdictional regulatory expectations.
Whether supporting the design and implementation of a new QMS, conducting gap and risk
assessments of existing systems, or delivering quality systems training, we provide tailored
support through both on-site and remote engagements.
Compliant Documentation Architecture
Ensure quality standards and SOPs remain current, aligned with the latest regulatory
expectations across all applicable markets.
Refined, Usable Documentation
Develop QMS documentation that is clear, intuitive, and readily usable by end users, while
maintaining full regulatory and policy integrity.
Integrated Quality Systems
Ensure coherence across all QMS elements—including standards, SOPs, work instructions, and templates—delivering a unified and consistently structured system.
Optimized Quality Operations
Streamline quality systems by eliminating non-value-added requirements that lack regulatory or operational justification, thereby enhancing efficiency and reducing unnecessary resource
burden.
Compliant Documents
Ensure that your quality standards and standard operating procedures (SOP) are up-to-date, complying with the most current regulatory requirements of each marketed country.
Usable Documents
Ensure that your QMS documents are readable and easily understood by end user without compromising internal policies or regulatory requirements.
Integrated Documents
Ensure that documents (e.g., quality standards, SOPs, Work Instructions, Templates) provide requirements and instructions in a manner that is cohesive and consistent across the QMS.
Efficient Quality Systems
Ensure efficient processes by eliminating requirements that lack a regulatory basis or justifiable necessity for inclusion in the QMS. Decrease resource usage by streamlining and simplifying processes.
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.
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.
Dr. Constance Y. Fears
Meet Our Founder & Principal Polymath
Constance 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, US FDA Certified Drug Investigator 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.