Jian Lu

Regulatory Affairs Practice – U.S.

BACKGROUND

FOCUS AREAS

Over 15 years of experience in the design/performing/presenting of nonclinical studies. 3 years of experience in regulatory service.

Biopharmaceuticals
Blood factors
Cytokines
Vaccines
Antibodies
Antibody-drug conjugates
Recombinant therapeutic protein

As a nonclinical consultant, Jian Lu is responsible for helping the client with study design, performing gap assessment, drafting and reviewing regulatory dossiers.

With over 15 years of experience in the design/performing/presenting of nonclinical studies, Jian brings his extensive knowledge in toxicology, microbiology, and immunology to the regulatory service, including evaluation/summarization/presentation of nonclinical data to support clinical trials.