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.

Clinical and Regulatory
Dr. Li

CMC for Large Molecule and other Biologics
Dr. Liu

CMC for Gene and Cellular Therapy
Dr. Areman

Non-Clinical and Toxicology
Dr. Dixit

Biostatistician
Dr. Zhang

Clinical Pharmacology
Dr. Criste

Principal Consultant
Dr. Bashir

Medical Writing
Dr. Yan

Project Management
Ms. Belli

Medical Device Consultant
Dr. Chen

Chief Clinical Consultant
Dr. Stojadinovic

Clinical and Regulatory
Dr. Li

CMC for Large Molecule and other Biologics
Dr. Liu

CMC for Gene and Cellular Therapy
Dr. Areman

Non-Clinical and Toxicology
Dr. Dixit

Clinical and Regulatory
Dr. Li

Biostatistician
Dr. Zhang

Clinical Pharmacology
Dr. Criste

Principal Consultant
Dr. Bashir

Medical Writing
Dr. Yan

Chief Clinical Consultant
Dr. Stojadinovic

BD Expert