Merck

Andre Pearson is a highly experienced regulatory CMC strategy lead and medical writer, currently serving as the CEO and founder of Biotech Generics LLC since 2010. They have developed extensive CMC product strategies and managed global regulatory submissions across various roles, including Principal Medical Regulatory Writer at the University of Pennsylvania and Senior CMC Regulatory Affairs Specialist at Ipsen Biopharmaceuticals. Andre holds a Master of Science in Chemistry from Wesleyan University and a Bachelor of Science in Chemistry from UDC. Their work includes authoring important regulatory documents, leading interactions with global regulatory authorities, and providing strategic guidance for clinical trials and product approvals.

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