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
CMC for Small Molecule
Mr. Sinha
Non-Clinical and Toxicology
Dr. Dixit
Biostatistician
Dr. Zhang
Consultant for Oncology Regulatory Strategy
Dr. Williams
Clinical Pharmacology
Dr. Criste
Principal Consultant
Dr. Bashir
Medical Writing
Dr. Yan
Medical Writing
Ms. O’Connor
Project Management
Ms. Belli
Medical Device Consultant
Dr. Chen
Clinical and Regulatory
Dr. Li
CMC for Large Molecule and other Biologics
Dr. Liu
CMC for Gene and Cellular Therapy
Dr. Areman
CMC for Small Molecule
Mr. Sinha
Non-Clinical and Toxicology
Dr. Dixit
Clinical and Regulatory
Dr. Li
Biostatistician
Dr. Zhang
Consultant for Oncology Regulatory Strategy
Dr. Williams
Clinical Pharmacology
Dr. Criste
Principal Consultant
Dr. Bashir
Medical Writing
Dr. Yan
Medical Writing
Ms. O’Connor
Project Management
Ms. Belli
Medical Device Consultant