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Farhad Amiri, PhD, FAHA

Principal Regulatory Consultant
Parexel International

Skilled regulatory consultant with both extensive non-clinical and regulatory R&D experience, including over 10 years of experience as a Sponsor in both Biotechs and large pharma, with significant experience in non-clinical study management across multiple therapeutic areas encompassing both small molecules and biologics in multiple indications. Internationally recognized for scientific knowledge of multidisciplinary fields ranging from cardiovascular, dermatology, endocrinology, and immunology, as well as in-depth regulatory experience in drug approval for FDA and Health Canada.

Subject matter expert with FDA, Health Canada, EMA and APAC drug regulatory requirements in multiple therapeutic areas and indications including but not limited to Dermatology, Neurology (Multiple Sclerosis), Infectious Diseases, Ocular Diseases, Nephrology, Oncology, Cardiovascular medicines, for biologics and small molecules involving different application types such as FDA IND, NDA and BLA, Health Canada CTA and MA, EMA CTA and MAA.

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