BACKGROUND
FOCUS AREAS
10+ years experience in pharmaceutical industry and CMC regulatory affairs.
- IND
- NDA
- BLA
- Post-Approval Change Control
As a senior CMC consultant, Junjie Gao helps clients to satisfy CMC regulatory requirements from global health authorities.
Junjie provides CMC consulting services from early drug development to marketing application. Junjie has more than 10 years experience of CMC regulatory affairs in small molecule drugs, biologics, and complicated entities such as antibody drug conjugates (ADCs). He has successfully helped clients to get approvals for more than 30 INDs and several NDAs/BLAs.
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EDUCATION:
- Ph.D., The University of Alabama
- Master of Science, East China University of Science and Technology
- Bachelor of Science, East China University of Science and Technology
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PROFESSIONAL EXPERIENCE:
- Pharmaceutics International, Inc Analytical Chemist
- University of Maryland, Baltimore Research Specialist
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