Our Team

Cynthia joined Biologics Consulting in June 2026 and has over 5 years of drugs/combination products industry expertise. With specialized expertise in client relationships, cross-functional teams project management, US regulatory strategies and IND eCTD submissions, she has successfully managed numerous projects. Her extensive experience includes handling PINDs, INDs, EOP1s, EOP2s, NDAs, BLAs, FTs, BTDs, iPSPs and ODD submissions. Additionally, she has facilitated numerous interactions and meetings with the FDA, ensuring compliance and smooth regulatory processes. Her commitment to excellence and strategic approach continue to drive successful outcomes for clients.

With a strong background in regulatory affairs, Cynthia brings a wealth of knowledge and a keen eye for detail to every project she undertakes. Her proficiency in navigating the complexities of regulatory submissions and her ability to streamline the process have been instrumental in achieving timely approvals. She is adept at eCTD publishing quality control, ensuring that all documentation is meticulously prepared and submitted.
Her project management skills are complemented by her strategic insight into US regulatory landscapes. She is known for her ability to develop and implement effective regulatory strategies that align with both client business goals and regulatory expectations.

Cynthia serves as the US Agent/Regulatory Representative for many Sponsors. Her experience in managing interactions with the FDA, including face-to-face meetings and written correspondence, has been pivotal in fostering positive relationships and facilitating smooth communication between clients and regulatory bodies. Her dedication to staying current with regulatory trends and changes ensures that her clients are always well-prepared and informed.
Cynthia holds a Master of Science in Public Health from Johns Hopkins Bloomberg School of Public Health (2021), a Master of Business Administration (2024), and a Bachelor of Science in Public Health from Sun Yat-Sen University (2019). Her multidisciplinary background has provided a strong foundation and combination in public health, business strategy, and project management, enabling her to support complex healthcare research, and regulatory activities.