About RegChoice
RegChoice is a consulting firm specializing in activities with products regulated by the U.S. Food and Drug Administration (FDA) and other regulatory agencies. Our team of experienced scientists and regulatory professionals draw on years of experience working across a wide variety of regulated products. RegChoice is focused on increased connections, both worldwide and locally, customer service, and providing advice and work products for an increasingly diverse set of regulatory needs.
Our company addresses clients’ individual needs with respect to their product(s) in any phase of their life cycle. Our projects span prescription and non-prescription drugs, Class I, II and III devices, drug/device combinations, biologics, dietary supplements, and food products. We lead or assist interactions with FDA. Drug and biologics-related projects have included phases such as Pre-INDs, INDs, NDAs, ANDAs, BLAs, supplements for applications to FDA, and the associated approval procedures. Clients use us to navigate the Monographs relating to drugs in the CFR and Federal Register. Additionally, we help develop and execute FDA device submissions for Pre-Subs, IDEs, 510(k)s, the De Novo pathway and PMA product lines.
We have addressed client needs related to FDA and/or NIOSH policies and guidances issued in response to COVID-19 (SARS-CoV-2): surgical masks and respirators, surgical gowns and surgical isolation gowns, treatments, hand sanitizers and different types of testing kits. RegChoice professionals have years of experience with these types of devices as well as drug/topical treatments, but also understand the details of the current emergency needs and FDA’s responses to submissions during the COVID-19 pandemic. We also aid in planning a transition to the time when FDA lifts the emergency policies so that clients can remain in compliance with FDA regulations.
