Our Team

Guangyuan (Claire) Li joined Biologics Consulting in August 2025 and has over five years of regulatory affairs experience spanning early- to late-phase clinical trial applications across a broad range of therapeutic areas. Her expertise includes regulatory consulting, regulatory project management, and eCTD submissions. Claire has broad experience with small molecules, biologics, and cell and gene therapy products, and is familiar with FDA regulations, guidance documents, and regulatory procedures at CBER and CDER.

She has led and supported a variety of regulatory submissions, including INTERACT, pre-IND, and end-of-phase meeting briefing packages; INDs and amendments; orphan drug designation (ODD) applications; initial pediatric study plans (iPSPs); expedited program requests; and marketing applications. Claire provides regulatory guidance to ensure the preparation of high-quality, compliant submissions in eCTD format and is proficient in electronic publishing tools and FDA submission requirements.

Prior to joining Biologics Consulting, Claire served as a Senior Regulatory Specialist at ELIQUENT Life Sciences, where she managed multiple regulatory projects, acted as U.S. Agent for Sponsors, and supported the preparation and submission of applications in eCTD format. She maintained regular communication with FDA staff at CBER and CDER and participated in FDA – Sponsor meetings. Earlier in her career, she was a Project Manager at WuXi Biologics and an ORISE Research Fellow at the U.S. FDA, where she conducted regulatory science research in
the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), building on her molecular biology research background in academic institutions.

Claire holds a Ph.D. in Zoology and Physiology and a B.Sc. in Physiology from the University of Wyoming. She is RAC-certified and fluent in English and Mandarin Chinese.