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
Chief Clinical Consultant
Dr. Stojadinovic
CMC for Large Molecule and other Biologics
Dr. Liu
Principal CMC consultant and writer
Mr. Sinha
Principal CMC Consultant (ex-FDA Reviewer)
Dr. Lin
Non-Clinical and Toxicology
Dr. Dixit
Pharmacology and Toxicology
Dr. Yang
Biostatistician
Dr. Zhang
Clinical Pharmacology
Dr. Criste
Principal Consultant
Dr. Bashir
Medical Writing
Dr. Yan
Project Management
Ms. Belli
Project Management
Mr. He, MSc.
Project Management
Dr. Gurjar
Medical Device Consultant
Dr. Chen
Medical Device Consultant
Dr. Li
Medical Device Consultant
Dr.Yan
eCTD Function
Ms. Osada
eCTD Function
Ms. Leung
BD Expert
Dr. Wang
Clinical and Regulatory
Dr. Li
Chief Clinical Consultant
Dr. Stojadinovic
CMC for Large Molecule and other Biologics
Dr. Liu
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
Medical Device Consultant
Dr. Chen
Medical Device Consultant
Dr. Li
Medical Device Consultant
Dr.Yan
Project Management
Dr. Gurjar
BD Expert