FDA

Assessment for pharmaceutical contract manufacturing organizations covering cGMP compliance, quality agreements, and third-party oversight

FDA 21 CFR Part 11 Electronic Records Compliance

Evaluate compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in FDA-regulated industries

FDA 21 CFR Part 820 QSR Assessment

Evaluate compliance with FDA Quality System Regulation for medical device manufacturers - the U.S. equivalent of ISO 13485

FDA AI/ML Software as Medical Device (SaMD)

Evaluate FDA AI/ML-based Software as Medical Device compliance per 2021 guidance, covering predetermined/adaptive algorithms, algorithm change …

FDA Drug Supply Chain Security Act (DSCSA)

Evaluate DSCSA compliance for pharmaceutical track-and-trace, serialization, verification, and transaction history requirements

FDA Mobile Health App Compliance

Evaluate mobile medical app compliance with FDA guidance, 21 CFR Part 11, data security, clinical validation, and app store requirements

Good Clinical Practice (GCP) Compliance Assessment

Evaluate compliance with international ethical and quality standards for clinical trial design, conduct, and reporting

Good Manufacturing Practice (GMP) Assessment

Evaluate compliance with FDA Good Manufacturing Practice regulations for pharmaceutical and biotech manufacturing quality systems

MDSAP Readiness Assessment

Evaluate readiness for Medical Device Single Audit Program certification covering FDA, Health Canada, TGA, PMDA, and ANVISA requirements in one audit