MIAMI, June 23, 2022 /PRNewswire/ -- Brand Institute, the global leader in pharmaceutical and healthcare-related name development, recently celebrated the 15-year anniversary of former FDA Team Leader, Dr. Nora Roselle, with Brand Institute/Drug Safety Institute.
Dr. Roselle joined Drug Safety Institute (DSI) as Managing Director of U.S. Regulatory Affairs in May 2007, and later as Vice President, Global Regulatory Affairs in 2012. In January 2020, she was promoted to her current role as President, U.S. Regulatory Affairs. Dr. Roselle oversees all U.S. brand nomenclature safety assessments and FDA name submissions. Her responsibilities at DSI include assisting clients with their U.S. proprietary brand and line extension strategy, naming, safety research, labeling, risk management, rebuttals, and special consults. She has been supporting the branding community with her FDA regulatory experience for more than 20 years.
Prior to DSI, Dr. Roselle served as an officer (LCDR) in the U.S. Public Health Service. She joined the U.S. Food and Drug Administration (FDA) in 2001 as a Safety Evaluator in the Division of Medication Errors and Technical Support (DMETS), in the Office of Drug Safety (ODS), renamed the Office of Surveillance and Epidemiology (OSE), now known as the Division of Medication Error Prevention and Analysis (DMEPA). DMEPA is responsible for the approval of manufacturers' drug/biologic brand names and human factors/medication error evaluation of drug and drug/device labeling, packaging, and product design to reduce medication errors. In July of 2006, Dr. Roselle was promoted to a more senior management position as a Team Leader in DMETS, managing DMETS safety evaluators, proprietary (brand, line extension, and combination product) name reviews, labeling and risk management consults.
About Brand Institute and its wholly owned subsidiary, Drug Safety Institute
Brand Institute is the global leader in brand name and identity development, providing a broad portfolio of branding and naming related services, including brand strategy, name development, trademark searches, market research, regulatory services, and visual identity solutions.
Drug Safety Institute (DSI) is a wholly owned subsidiary of Brand Institute that provides Brand Institute's healthcare clients with industry-leading guidance pertaining to drug name safety, packaging, and labeling. DSI is comprised of former naming regulatory officials from global government health agencies, including FDA, EMA, Health Canada, AMA, and the WHO.
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SOURCE Brand Institute, Inc.