Ensure Your QMS is Current and Compliant
Quality Management Systems
Did you know that lack of adequate procedures is often the most cited FDA 483 observation?
Polymath consultants have industry experience in authoring QMS documents for globally-marketed products and reviewing documents for compliance with multi-country regulatory requirements.
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 Commodities Expertise
Prescription 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 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.
Compounded Drugs
We offer quality and GMP solutions for compounded drugs in all forms including, oral dosages and injectables. We realize that compounded drugs provide major cost savings to customers and healthcare partners. Let us keep your operations compliant with federal laws and regulations.
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 products, including finished goods and raw materials for use in various industries.
Dr. Constance Y. Fears
Meet Our Founder & Principal Polymath
Constance Fears brings almost two decades of technical, legal, and 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, 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.