Leadership at bioLytical®

Ana Subramanian

Director of Quality and Regulatory Affairs

Ana has over 12 years of experience in quality and compliance in the pharmaceutical, biotech, and medical devices fields. In her current position, Ana guides bioLytical’s regulatory and quality process playing a key role in attaining regulatory approvals, registering and commercializing the INSTI product line, and maintaining the quality management system (QMS) to maintain MDSAP/ISO 13485 requirements.

Before rejoining bioLytical in 2021, Ana spent ten years working in research, audit, and consultancy roles establishing, implementing, and ramping up phase-appropriate quality systems from the ground up in pre-clinical, clinical, and commercial medical device environments. She also has a proven track record in developing and implementing a strong and impactful quality vision and culture across multiple organizations. Before joining bioLytical, Ana worked for BSI (Notified Body) as a Lead Auditor, where she assessed various medical device manufacturers for their quality systems compliance.

With an impressive academic background, Ana has a Ph.D. in Chemistry and post-doctoral experience from the University of Miami and has published international research articles. In addition, Ana holds a Regulatory Affairs Certification (RAC) and has a vast knowledge of industry-leading audit practices. Along with her extensive experience, Ana’s academic background allows her to commercialize ground-breaking technology for safe use.