Genabio Diagnostics
Han Si is a skilled Regulatory Affairs and Quality Assurance Specialist currently employed at Genabio Diagnostics since February 2024, where responsibilities include assisting in the successful submission of 510k and CLIA Waivers and engaging in FDA communication for technical inquiries. Prior experience includes a Capstone Project at BLA Regulatory focused on FDA fast-track drug approval strategies, a Quality Regulatory Compliance Intern role at AG Mednet overseeing quality management systems, and several Quality Assurance positions at Melville Candy Co and Belfonte Dairy, where Han Si developed quality systems and compliance programs. Educational qualifications include a Master of Science in Regulatory Affairs from Northeastern University and a Bachelor of Science in Dairy Manufacturing from South Dakota State University.
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Genabio Diagnostics
Genabio is a global leader in the production of over-the-counter self-testing products, with an impressive sales record of over $100 million in the past three years. Our extensive customer base spans across the USA, Canada, the UK, Japan, and India. A significant aspect of our product range is their FDA approval, including the COVID-19 self-test. These sought-after products can be found in thousands of locations, including renowned pharmacy chains like Walgreens, leading hospitals such as NYU Langone Health, accredited laboratories like SV Diagnostics Labs and Molecular Testing Labs, and various government departments. In 2023, Genabio marked a pivotal moment by initiating our listing and financing efforts in Hong Kong. Simultaneously, we are focused on enhancing our brand identity and emphasizing clinical research within the United States. This commitment to research and development aligns with our expansion plans, which encompass increasing our production capacity in both the United States and China. Our overarching vision is to be the world's foremost provider of self-testing solutions, offering precise, user-friendly, and cost-effective health diagnostics for individuals worldwide. Our Mission is to enhance global health awareness and accessibility, by delivering quality, FDA-approved self-test kits, by driving innovation, and by expanding our reach to ensure individuals can monitor their health with precision and convenience.