Polymath Regulatory Consultants, LLC

About Us

We are ex FDA consultants helping manufacturers remain compliant with laws, regulations and industry standards. We specialize in Drugs (OTC and Rx), Cosmetics, Personal Care Products Quality, and other ISO-certified and GMP-regulated products.

We have expertise in:
-GMP/ISO Audits
-Permanent Inspection Readiness planning and support
-GMP Training
-Quality Management Systems (QMS)
-FDA/International Health Authority Inspection support and remediation
-FDA 483 and Warning Letter remediation
-Complex Quality and GMP Compliance Advisement
-GMP subject matter expertise for Artificial Learning and IT Platforms

https://m.youtube.com/@PolymathRegConsultants