Be More Compliant. Get More Done.
The Kymanox Audit Team consists of Certified Auditors and seasoned Subject Matter Experts (SMEs) across a wide variety of disciplines with extensive expertise in preparing your company for regulatory body inspections and performing internal audits, external audits, gap assessments, and due diligence evaluations. We manage and execute CMC, clinical, laboratory, and supply chain audits around the world, including support for Pre-Approval Inspection (PAI) readiness.
Global Audit Support
Our CGMP, GCP, and GLP audits support the full product life cycle from raw material to finished product to patient use. We have experience with novel, high-risk, complex products (e.g., biologic with multi-use auto-injector). Kymanox provides detailed, timely documentation and personalized support utilizing a risk-based approach. Kymanox is committed to following up on all audit findings and addressing all corrective actions — including best-in-class recommendations for remedy — with the audit sponsor and auditee.
Our team has created turnkey toolkits and checklists, as available on www.KymanoxWORKS.com, that provide everything needed for the auditing process, including templates for quality agreements, audit notifications and agendas, audit summary reports, and various risk assessments. Kymanox follows industry best practices in audit execution consistent with the American Society for Quality’s (ASQ’s) approach to quality auditing.
Kymanox provides expert audit support in the following areas:
- PAI Preparation, Execution, and Remediation
- FDA 483 and Warning Letter Response
- Global CGMPs, GCP, and GLP
- Routine Maintenance Audits
- Mock Biannual Inspections
- Periodic Internal Audits
- Supplier Qualifications (e.g., Raw Materials, Warehouse, Manufacturing, Laboratories, Distribution/3PL)
- Consent Decree Management
- 503B Outsourcing Facilities
- 21 CFR 210, 21 CFR 211, 21 CFR 820, 21 CFR Part 4, 21 CFR Part 11
- ISO 9001, ISO 13485, ISO 14971, ISO 11137, ISO 17025, MDR
- EMA (EU), MHRA (UK), Health Canada, COFEPRIS (Mexico), ANVISA (Brazil), PMDA (Japan)
- International Council for Harmonisation (ICH) Guidelines
Our responsive, expert-led teams are rich in knowledge and experience spanning all aspects of life sciences, including biomedical development, translational medicine, and best-in-class quality management. Together with you, we ensure value-driven, solution-based, compliant approaches to support your quality audits.