About me
Harsh Shah is Co-Founder and CEO of Clinplex, an AI regulatory intelligence company focused on continuous compliance assessment for pharmaceutical, biotech, and medical device organizations. He brings 16+ years of pharmaceutical Quality Assurance and Regulatory Affairs experience from Johnson & Johnson and Leidos Biomedical Research (NCI Frederick), spanning preclinical through post-market surveillance. He holds an MBA, an MS in Biotechnology Management, and is a Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Six Sigma Black Belt (CSSBB). His current work focuses on multi-framework regulatory gap detection methodologies and validation of AI-assisted compliance assessment.
