Ana Subramanian
Chief Scientific Officer
Ana brings over 18 years of experience spanning scientific research, quality and regulatory affairs, biotechnology, in-vitro diagnostics, and medical devices to her role at bioLytical. As Chief Scientific Officer, she provides scientific and strategic leadership across product development, clinical evaluation, regulatory approval, and commercialization of the company’s INSTI®, iStatis™, and TruPlex™ diagnostic platforms. Since rejoining bioLytical in 2021, Ana has played a key role in advancing multiple diagnostic programs from development through clinical validation, regulatory approval, and commercialization. Her work spans scientific and product development strategy, clinical affairs, regulatory strategy, manufacturing, and quality, and she has contributed to innovative technologies that have resulted in four patent filings by bioLytical. Prior to rejoining bioLytical, Ana worked in scientific research, medical device auditing, and consulting, including serving as a Lead Auditor with BSI, where she assessed medical device manufacturers against international regulatory and quality management requirements. Ana holds a Ph.D. in Chemistry and completed postdoctoral research in Miami. She also holds a Regulatory Affairs Certification and has a strong record of scientific research and scholarly publications. Her combination of scientific, regulatory, clinical, and quality expertise enables her to bridge scientific innovation with the regulatory and operational requirements needed to bring novel diagnostic technologies from concept through commercialization.