Gail Radcliffe

Gail Radcliffe is the President of Radcliffe Consulting, Inc., a position she has held since founding the company in 1998. She is based in West Boylston, Massachusetts, and has extensive experience in the biotechnology field, particularly in clinical, regulatory, and quality aspects of medical devices and diagnostics.

Professional Background

Before establishing her consulting firm, Radcliffe worked at GENE-TRAK, where she developed in vitro diagnostic (IVD) assays for various infectious diseases. Her expertise encompasses over 20 years in the medical device and diagnostics industry, focusing on regulatory compliance and quality assurance.156

Contributions and Expertise

Radcliffe is recognized for her knowledge in biotechnology science and has contributed significantly to improving diagnostic testing technologies. She is also involved as a regulatory advisor for Boston Cell Standards, where she helps enhance quality assurance in immunohistochemistry.123

Her professional journey reflects a strong commitment to advancing medical diagnostics, and she is noted for her business acumen in navigating the complexities of the biotechnology landscape.24