Polymath Services
Inspection Support
Assistance with U.S. and international Health Authority GMP inspections including but not limited to, inspection readiness, inspection management and support, response writing, and Agency communication.
Training/Learning & Development
Development of curriculum/training, e.g., internal auditing program training, annual GMP training and compliance-based review of new or existing training programs.
Post-inspection Remediation
Assistance and leadership in remediation efforts after an unfavorable inspection or audit report, Warning Letter, or Non-compliance report.
Quality & Compliance Advice
Risk-based advisement on complex quality and quality compliance matters.
Site GMP Audits
Conducting site GMP audits to meet regulatory requirements or in preparation for an inspection.
Quality Management System (QMS)
Authorship and compliance-based review of QMS documentation, e.g., Quality Standards, SOPs.
Artificial Learning and IT Platforms
Supplying GMP subject matter and inspectional expertise to companies developing software for life sciences and pharmaceutical companies.