Independent Expert
MLZ Biotech Consulting Inc
Michelle L Zaharik, PhD
Michelle Zaharik is a seasoned scientific expert with nearly 20 years of experience in the research, development, clinical, and regulatory pathways for In Vitro Diagnostics (IVDs). Specializing in Point of Care (POC) and Self-Tests, including central laboratory tests and LDTs to innovative diagnostics for low- and middle-income countries (LMICs), Michelle has successfully guided numerous products from concept to commercialization including obtaining Health Canada, US FDA (PMA, 510k), EU and WHO PQ approvals.
Currently, Michele provides consulting services specializing in Product Development, Quality Management, and Regulatory Affairs. With a passion for advancing healthcare in underserved regions, she has played a pivotal role in the development and regulatory support of diagnostics, focused on affordable POC platforms for LMICs.
With extensive project management expertise, Michelle has managed multiple simultaneous projects, interfacing with diverse stakeholders such as industry partners, government agencies, and CRO/CMOs. Her leadership has been instrumental in advancing diagnostic technologies, ensuring they meet regulatory requirements and market needs, particularly in the context of global health challenges.
Wednesday, April 23, 2025
2:15 PM – 3:15 PM East Coast USA Time