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Meredith Brown-Tuttle, FRAPS

Chief Regulatory Strategist
Regulatorium

Meredith Brown-Tuttle, FRAPS, has over 33 years’ experience in the drug and device industry. She is the Chief Regulatory Strategist for Regulatorium, working with small/medium drug, biologic, and combination companies to successfully navigate global regulatory submissions, writing, intelligence, and strategy requirements. She has held senior regulatory positions at San Francisco Bay Area biotech companies writing INDs, NDAs, key meeting packages such as Pre-NDA and EOP2, negotiated NDA/BLA filings and providing key drug development strategic insights. In addition to US clients, she has been a US agent and strategist for Australian, Canadian, European, Japanese, and Israeli companies.
Meredith studied biological psychology as an undergraduate at San Jose State University. Her goal in life is to evolve and streamline global regulatory science through the development of AI tools. She is author of over 70 articles, 2 books (IND Submissions: A Primer and Regulatory Intelligence 101) and training thousands on how to write INDs and conduct strategy.

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