Drug Development and Regulatory Affairs (US FDA/China CFDA)

Overall Drug Development

1. All aspects (preclinical, clinical, chemistry manufacturing, and control, investigator’s brochure) of drug development of small molecules, biologics, proteins, peptides, genetic & protein-based vaccines and botanical products
    

2. Project Management
    

3. IND/NDA submissions to US FDA and China CFDA
    

Preclinical Drug Development

1. Toxicology, PK/Metabolism, Safety Pharmacology, Genetic Toxicology, and efficacy modelings
    

2. Preclinical GLP laboratory design and building per AAALAC requirement
    

3. Alliance with many pathology, toxicology, and pharmacology labs in China and U.S.
    

4. Report writing in both English and Chinese