Meet the Team
At Clinplex, it all starts with your vision. Whether you’re developing a groundbreaking drug, optimizing clinical operations, or advancing healthcare innovation, we transform your ambitions into reality with precision and expertise.
Co-Founder & Regulatory Affairs Leader
Nidhi Shah, MS, MBA
Nidhi brings over 15 years of expertise in regulatory affairs and CMC for biologics and small molecules at AstraZeneca. A Six Sigma Green Belt, she excels in regulatory excellence, health authority interactions, and cross-functional leadership, achieving 100% on-time delivery for regulatory submissions.
Co-Founder & Quality Assurance Leader
Harsh Shah, MS, MBA,
With over 15 years of experience, Harsh is a Certified Six Sigma Black Belt and ASQ CMQ/OE, specializing in QA, compliance, and clinical operations. He has led cross-functional teams at Leidos, Johnson & Johnson, Clinical Labs and Biotech driving compliance with FDA, ISO, and WHO standards while reducing risks by 30%.