Eric Zhang
Founder & Principal Consultant
About
More than 20 years combined working experience from big pharma, regulatory agency, clinical CRO, and small biotech; Insight on drug development with respect to regulatory strategy (e.g., consultation meetings with FDA, orphan drug/breakthrough designation, 505b2 eligibility, and IND/NDA/BLA submission) & compliance (GLP, BE, & GCP audit), and clinical pharmacology strategy (specialty in designing bridging study for 505b2).
United States
Washington DC-Baltimore Area
Pharmaceuticals
Good Clinical Practice (GCP), Pre-clinical Studies, Biotechnology, Clinical Development, Drug Development, Regulatory Affairs, Drug Discovery, Pharmaceutical Industry, Clinical Research, Clinical Pharmacology, Clinical Trials, IND
Experience
Founder & Principal Consultant
AmberSight LLC
Rockville, Maryland, United States
With 20 + years combined working experience from big pharma, regulatory agency, clinical CRO, and small biotech, Eric provides consultation to pharmaceutical clients on drug development especially with respect to regulatory strategy (e.g., consultation meetings with FDA, orphan drug/breakthrough designation, 505b2 eligibility, and IND/NDA/BLA submission) & compliance (GLP, BE, & GCP audit), and clinical pharmacology strategy.
Head of International Regulatory Science
AffaMed Therapeutics
VP
dMed Biopharmaceutical Co., Ltd. dba Caidya
Regulatory Affairs & Strategy
Compliance Officer
FDA
Silver Spring, MD
CDER Office of Compliance Office of Scientific Investigation
Clinical Pharmacologist
FDA
Silver Spring, MD
CDER Office of Clinical Pharmacology
Principal Scientist
Pfizer
La Jolla, California
Postdoc Fellow
Eli Lilly and Company
Indianapolis, Indiana
Graduate student
The Ohio State University
Education
The Ohio State University
Pharmaceutical Sciences
University of California, San Francisco
American Course on Drug Development and Regulatory Sciences (ACDRS)
China Pharmaceutical University
Pharmacy
Eric Zhang's Contact Information
Phone
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