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FarhadAmiri

PhD, FAHA

Principal

Headshot of Farhad Amiri, PhD, FAHA, Syner-G BioPharma

Farhad brings more than 20 years of experience across clinical drug development and global regulatory affairs, with deep expertise guiding complex programs from early development through marketing authorization. He partners with biotech and pharmaceutical companies to develop integrated nonclinical and clinical regulatory strategies that align with global regulatory expectations, drawing on experience across oncology, CNS, cardiology, infectious disease, and rare disease, as well as biologics, small molecules, cell and gene therapies, vaccines, and biosimilars. He has led and supported more than 45 regulatory submissions across major health authorities, including the FDA, EMA, MHRA, and Health Canada, with expertise spanning regulatory interactions at every stage of development, from early advisory meetings through IND, CTA, NDA, and BLA submissions.

Prior to joining Syner-G, Farhad held senior leadership roles in regulatory strategy, toxicology, and scientific affairs, where he led global development programs and managed cross-functional teams overseeing nonclinical and clinical strategy across North America, Europe, and Asia. He holds a PhD in Biomedical Sciences from Université de Montréal and completed postdoctoral training in vascular biology and cellular signaling. He is a Fellow of the American Heart Association (FAHA) and maintains active expertise in Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

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