Validant
Kevin Amiri, PhD, RAC, is a highly experienced regulatory affairs consultant with a career spanning over a decade in the pharmaceutical and biopharmaceutical industries. Currently serving as a Senior Regulatory Affairs Consultant at PAREXEL since May 2016, Kevin also provides regulatory consulting services at Validant and Pharmabiodevice. Kevin has a robust background in managing CMC regulatory changes for eCTD submissions and developing global filing strategies, with prior roles at notable companies including Sanofi, Pfizer, Merck, and Regeneron, where responsibilities included overseeing post-marketing CMC regulatory changes and ensuring compliance with health authority regulations. Kevin holds a Doctor of Philosophy (PhD) in Food Science and Technology from the University of Tennessee, Knoxville.
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Validant
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Validant is a full-service life science consulting firm serving developers and manufacturers of pharmaceuticals, biologics, medical devices, and diagnostics worldwide. We partner with these companies to ensure safe and reliable access to life-saving healthcare products, facilitating their efficient, compliant progression from preclinical and clinical phases through to manufacturing and distribution—and optimizing quality at each step. Our platform brings together leading specialists in each facet of the product lifecycle, and we have curated an extensive and diverse global network of consultants to help execute strategies worldwide. Because of this, Validant is able to deliver our breadth of consulting, execution, and support services in the right place, at the right level, and in the right combination to meet your exact need. We've empowered hundreds of clients – from start-ups to the largest global leaders – to efficiently navigate regulatory, compliance, and quality complexities. How can we help you?