About

About Me

I am Emy Li, holding a Ph.D. in pharmaceutical sciences, with extensive expertise in new drug registration and regulatory affairs, specializing in oncology, dermatology, and biologics. Throughout my career in the biopharmaceutical sector, I have held pivotal roles driving the development and regulatory approval of innovative therapeutics, ensuring adherence to stringent global standards. My proficiency spans the entire drug registration continuum, encompassing clinical trial applications (CTAs), regulatory authority engagements, biologics license applications (BLAs), and post-approval compliance management.

My professional accomplishments include independently managing and securing approvals for five CTAs—covering standalone drugs, combination therapies, and new indications—from submission through regulatory review, alongside preparing materials for additional filings. I have spearheaded over ten critical regulatory meetings, including Pre-CTA, End-of-Phase II (EOP II), and Pre-BLA consultations, while leading applications for Breakthrough Therapy Designations (BTD). My contributions extend to preparing comprehensive BLA documentation (Modules 1 through 5), securing CAS and INN designations for novel compounds, and overseeing development milestones, including DSURs, investigator brochures, and protocol amendments. Earlier in my career, I refined my skills in pharmacology and non-clinical data review, managed post-approval supplements for chemical drugs, and ensured successful re-registration of imported pharmaceuticals.

Motivated by a steadfast commitment to advancing medical science, I established this platform to provide rigorous, evidence-based insights and practical guidance on new drug registration. My objective is to offer a trusted resource for industry professionals and researchers navigating the complexities of regulatory frameworks. Every piece of content here is meticulously researched and reviewed, reflecting my dedication to scientific accuracy and regulatory precision.

Beyond this endeavor, I remain actively engaged with the latest advancements in pharmaceutical research, collaborating with thought leaders to align my expertise with the field’s evolving frontiers. Thank you for visiting—I aspire for this platform to serve as a robust tool in supporting your endeavors in drug development and registration.