GMP and ISO Audits
Drugs – Cosmetics – ISO-certified Products
We believe that audits should be affordable without compromising rigor and quality standards. Our former FDA inspectors conduct GMP & ISO audits in as little as one day. Let our consultants perform your supplier/vendor qualification, requalification, and specialty audits at competitive rates.
Our Audit Services
Our team is among the best in the industry! We are former FDA inspectors and certified industry auditors who have decades of field experience with drug, cosmetic, and ISO audits. We don’t just box check – we write comprehensive audit reports with observations and recommendations that improve your manufacturing practices and quality compliance.
We have teamed up with Atlas-Compliance, the premier FDA inspection platform for insights and research, to bring cutting-edge artificial intelligence services to our clients. This partnership means that we can utilize FDA and industry trends to ensure you remain compliant with the most current regulatory expectations.
We can also perform audits of your contractors, suppliers and vendors. By ensuring that third parties meet CGMP requirements and ISO standards, your supply chain, product quality, customer confidence and brand reputation remain at the highest standard.
Supplier & CMO Audits
- Active Pharmaceutical Ingredients (APIs)
- 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 SIZE IS OUR STRENGTH
Our Commodities Expertise
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.
ISO 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.