Erkang Ai, Ph.D.
A geneticist and biologist by training, Erkang Ai works closely with clients to navigate the complex FDA regulations. Speaking both languages of lawyers and scientists, he brings his technological know-how to assist medical device, diagnostics, and biologics companies in the most challenging legal and regulatory issues.
Erkang holds a doctorate degree in genetics. Prior to attending Harvard Law School, he also worked as a postdoctoral fellow at Stanford University. With 10 years of research experience, he has gained a deep understanding of genetics, genomics, oncology, biochemistry, and cell biology. He is passionate about leveraging his scientific and legal background to help companies bring their cutting-edge medical products to market.
Erkang's practice focuses primarily on premarket clearance or approval of medical devices. His experience includes evaluating the FDA's market requirements, designing analytical and clinical development plans, and formulating innovative regulatory strategies. He is also skilled in the regulation of in vitro diagnostic assays, including NGS-based genetic tests and laboratory developed tests.