Gail Radcliffe, PhD

Regulatory Advisor

President Radcliffe Consulting, Inc.

Gail E. Radcliffe, Ph.D. has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment and clinical/regulatory issues.  Gail founded Radcliffe Consulting in 1998 after having worked at GENE-TRAK, where she developed IVD assays for several infectious disease organisms including HIV, CMV, TB, and Chlamydia and was responsible for instituting the clinical affairs group. She later joined Cytyc Corporation where she identified novel applications for the ThinPrep Processor and helped forge partnerships with other health care companies to expand product offerings.

As a consultant, Gail has provided assistance to start-up and established medical device companies with regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development, and clinical trial support.   Consulting engagements have encompassed a wide range of products including cutting-edge digital pathology instruments, stem cell laser dissection devices, companion diagnostics, and multiplex molecular, NGS, POC, and CLIA Waived in vitro diagnostic devices.  She has been working around the clock with manufacturers and laboratories developing SARS-COV-2 diagnostic products as a regulatory consultant with the RADx program.  This program is an NIH-funded initiative for the Rapid Acceleration of Diagnostic Products to get everyone back to school and work.

Gail obtained a Ph.D. in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School.

She is a member of the Regulatory Affairs Professional Society (RAPS), the American Society of Microbiology (ASM), and Sigma Xi.  She is on the Board of Trustees of the Massachusetts Biomedical Initiatives and acts as an advisor to venture capital companies.

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