Leung & Associates

Consultant Name

Kiu Leung


  • Law & Regulatory Compliance

Contact Information


3303 Glacier Ridge Road
Middleton, WI 53562




E-mail Kiu Leung


Executive leadership in Quality Assurance, Manufacturing, Research & Development
Unique industrial biomedical expertise spanning development to product launch


Seasoned biochemist, clinical chemist, endocrinologist and immunologist with over 22 years of experience in the in vitro diagnostics/pharmaceutical industry, contract research organization, CLIA and at respected academic institutions.


Assists clients with GxP expertise (GLP, GMP, and GCP) to implement quality management system for commercialization and regulatory compliance.

Assists client to assemble and submit 510(k) and PMA

• Formulated regulatory strategy to commercialize in vitro diagnostics including implementation of quality management system
• Developed quality systems to manufacture Laboratory Developed Tests

Background Information

Kiu received his PhD in Biochemistry from McGill University in Montreal, Canada, and his immunology training from Scripps Clinic & Research Foundation, La Jolla, California. He has worked at three start-up companies (IVD & biologics), Abbott, Sanofi Diagnostics, Specialty Laboratories, and Covance.

E-mail Kiu Leung

Contact Info:
Additional Information: