GMP and ISO Audits
We believe that audit excellence should remain both accessible and uncompromising in its rigor. Our team of former FDA professionals and CQA/ISO-certified experts delivers GMP and ISO audits with exceptional efficiency—often within as little as two days—without sacrificing depth or precision. We provide tailored support for vendor qualification, requalification, and
specialized audit services, all offered with a commitment to quality and thoughtfully structured, competitive engagement.
Our Audit Services
Our team represents a distinguished cadre of former FDA inspectors and CQA/ISO-certified
auditors, bringing decades of refined expertise across drug, cosmetic, combination product, and ISO auditing disciplines. Our approach is intentionally substantive—we move beyond checkbox compliance to deliver comprehensive, insight-driven audit reports featuring meaningful observations and strategic recommendations designed to elevate manufacturing performance and strengthen quality systems.
We have established a strategic partnership with Atlas-Compliance, a premier artificial
intelligence (AI) FDA inspection platform, to deliver advanced regulatory intelligence to our
clients. This collaboration enables us to integrate current FDA and industry trends into our
advisory approach, supporting sustained alignment with evolving regulatory expectations.
In addition, we conduct rigorous audits of contractors, suppliers, and vendors. By ensuring
third-party adherence to CGMP requirements and ISO standards, we help preserve the integrity of your supply chain while reinforcing product quality, customer confidence, and brand reputation at the highest level.
Supplier & CMO Audits
- Active Pharmaceutical Ingredients (APIs)
- Drug Substance
- Raw Materials
- Packaging & Labeling
- Excipients
- Other materials
QC Laboratory Audits
- Analytical Testing
- Microbiological Testing
- Stability Testing
- Organoleptic Testing
- Method Validation
Service Provider Audits
- Sterilization
- Packaging & Labeling
- Warehousing & Controlled Storage
- Distribution & Transportation
Specialty Audits
- Internal/Site
- Sterile Manufacturing
- Stability Programs
- Data Integrity
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.