Consultants

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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.

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Ms. Belli

Project Management

Senior Manager

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Ms. O’Connor

Medical Writing

Senior Medical Writer

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Dr. Criste

Clinical Pharmacology

Principal Consultant

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Dr. Dixit

Non-Clinical and Toxicology

Principal Consultant

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Dr. Areman

CMC for Gene and Cellular Therapy

Principal Consultant

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Dr. Li

Clinical and Regulatory

Founder & CEO

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Mr. Sinha

CMC for Small Molecule

Principal Consultant

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Dr. Liu

CMC for Large Molecule and other Biologics

Principal Consultant

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Dr. Williams

Consultant for Oncology Regulatory Strategy

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Dr. Zhang

Biostatistician

Principal Consultant