We conduct specialized audits of the critical hand-off points between clinical, laboratory, and manufacturing functions, ensuring an integrated Quality Management (QM) framework that eliminates compliance silos. Our team orchestrates comprehensive QMS audits to ensure medical device and pharmaceutical manufacturers remain compliant with 21 CFR Part 820, ISO 13485, and global GDP standards. We lead rigorous forensic audits of paper and electronic records, ensuring that every data interface meets the strict requirements of 21 CFR Part 11 and data integrity expectations.

We ensure the integrity of your non-clinical and clinical data through rigorous auditing of trial sites, laboratories, and study records. We provide specialized oversight to verify adherence to global safety and ethical standards, bridging the gap between raw data and regulatory submission. By integrating AI-enhanced risk assessments, we identify potential data discrepancies early, ensuring your path to market is built on a foundation of verifiable compliance. 

We offer GCP and GLP audit services.

We fortify pharmaceutical manufacturing compliance by conducting independent assessments of facilities against 21 CFR Part 211.

We streamline dietary supplement oversight by auditing production and labeling standards specifically for 21 CFR Part 111 compliance.