Consultants

Home Consultants

Our principal consultants all come from the pharma industry and the FDA with over 2 decades of experience on average. They specialize in major areas of regulatory affairs, such as regulatory strategy, operations, CMC, and medical. BLA’s consultants are former developers themselves, designing, drafting, and implementing global development programs.

Our regulatory consultants worked some of the high profile drugs, such as PD-1 and ADC for oncology. With 300+ IND applications and 50+ NDA packages, BLA’s regulatory consultants have the breadth and depth of hands-on experiences to help you develop the effective development programs.

Meet our principal consultants here. Or, contact us for a consultation.

Dr.Li 1

Clinical and Regulatory

Dr. Li
Dr.Liu

CMC for Large Molecule and other Biologics

Dr. Liu
Dr.Areman

CMC for Gene and Cellular Therapy

Dr. Areman
Dr.Dixit

Non-Clinical and Toxicology

Dr. Dixit
Dr.Zhang

Biostatistician

Dr. Zhang
Dr.Criste

Clinical Pharmacology

Dr. Criste
Dr.Bashir

Principal Consultant

Dr. Bashir
Dr.Yan 1

Medical Writing

Dr. Yan
Ms.Belli

Project Management

Ms. Belli
Dr.Chen

Medical Device Consultant

Dr. Chen
Dr.Stojadinovic

Chief Clinical Consultant

Dr. Stojadinovic
Dr.Li 1

Clinical and Regulatory

Dr. Li
Dr.Liu

CMC for Large Molecule and other Biologics

Dr. Liu
Dr.Areman

CMC for Gene and Cellular Therapy

Dr. Areman
Dr.Dixit

Non-Clinical and Toxicology

Dr. Dixit
Dr.Li 1

Clinical and Regulatory

Dr. Li
Dr.Zhang

Biostatistician

Dr. Zhang
Dr.Criste

Clinical Pharmacology

Dr. Criste
Dr.Bashir

Principal Consultant

Dr. Bashir
Dr.Yan 1

Medical Writing

Dr. Yan
Dr.Stojadinovic

Chief Clinical Consultant

Dr. Stojadinovic
Ms.Belli

Project Management

Ms. Belli
JY 01

Project Management

Dr. Yang
JH 01

Project Management

Mr. He, MSc.
Dr.Chen

Principal Medical Device Consultant

Dr. Chen
Dr.Li

Principal IVD and Software Consultant

Dr. Li
Dr.Yan

Principal Medical Device Consultant

Dr.Yan
YO 01

eCTD Function

Ms. Osada
YL 01

eCTD Function

Ms. Leung
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