Erkang Ai, Ph.D.

Erkang Ai, Ph.D.

Senior Associate

Email [email protected]​

Phone +1 267 675 4631

Fax +1 267 675 4601

LanguagesEnglish, Mandarin

Practice groupGlobal Regulatory

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.

Education and admissions


J.D., Harvard Law School, 2015

Ph.D., University of Wisconsin-Madison, 2010

B.S., Peking University, 2004

Bar admissions and qualifications


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