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Precision Medicine Group joins McKesson's Oncology & Multispecialty segment. Read more in McKesson Business Highlights.

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Sherma, Winston, MSc, RAC Avatar

Sherma Winston, MSc, RAC

Sherma Winston, MSc, RAC, is a Senior Director of IVD Regulatory Consulting within Precision for Medicine’s Translational and Regulatory Sciences Practice, with 14 years of experience supporting in vitro diagnostic development across U.S. and EU markets. Her expertise spans molecular diagnostics and NAATs, regulatory strategy from RUO to CTA to IVD, and marketing submissions for infectious disease, COVID-19, STI, and respiratory assays. She has led analytical validation strategies and regulatory submissions including Q-Submissions, EUAs, 510(k)s, Breakthrough Device designations, PMAs, and IVDR CE marking activities, and regularly serves as the client representative in FDA and EU Notified Body interactions.
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