Halteres Associates, LLC
Founded in 2002, Halteres Associates is a leading bioscience consultancy comprised of more than 200 professionals with extensive direct operating and managerial experience in a broad spectrum of areas of expertise, including research, development, manufacturing, regulation and commercialization of diagnostics, medical devices, therapeutics, research reagents, bioscience tools, and information and communications technologies (ICT). Halteres’ experiences extend from programs targeting High Income Countries to the design and implementation of specific, sustainable solutions in global health for Low and Middle Income Countries.
Experien Group, founded by Michael J. Billig and Darlene Crockett-Billig, is a regulatory consultancy with offices in San Jose and San Diego, California. They provide a full range of Regulatory, Quality and Clinical consulting services to medical device companies of all sizes. Experien Group’s senior team has more than 250 years of collective experience and will serve as a new extension of Imaging3’s organization, setting their regulatory strategy, compiling documentation, leading interactions with FDA and executing to major milestones, such as the filing and review of their 510(k) pre-market notification.