Reguliance LLC is a consulting firm based in Burlington, VT, specializing in US FDA regulatory affairs for pharmaceutical and biopharmaceutical development and commercialization. With over 18 years of experience, they offer a range of services including FDA regulatory insight, strategy, and support to small- and medium-sized domestic and foreign companies. Reguliance serves as the US Agent for several foreign pharmaceutical and biopharmaceutical firms, providing representation for various applications and registrations.
Their expertise lies in US regulatory affairs support for new drugs, generic drugs, biologics, advanced therapies, and combination products. Additionally, they offer specialized regulatory assistance for startup companies and conduct regulatory due diligence for licensing and acquisition purposes. Reguliance's ultimate goal is to help their clients achieve their regulatory development objectives and expedite the market entry of their products.
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