Clinplex

Clinplex is an AI regulatory intelligence platform for pharma, biotech, and medical device companies. We sit on top of existing quality management systems to surface compliance gaps, predictive risk, operational blind spots, and audit readiness issues across the full product lifecycle, from preclinical through post-market surveillance.
Our engine runs on 150+ regulatory frameworks including FDA 21 CFR Parts 11, 210, 211, and 820, the ICH Q-series, EU GMP Annexes, ISO 13485, and MDSAP.
Founded by a team with 16+ years of pharma QA/RA experience from Johnson & Johnson, Thermo Fisher, AstraZeneca, and NCI Frederick.
Your QMS tells you what you have. Clinplex tells you what's missing.