Fabrica Consulting

Fabrica Consulting is a private U.S. regulatory and clinical consulting firm focused on medical devices and combination products. The company provides strategic guidance spanning product development, First-In-Human study planning, clinical and regulatory submissions, and preparation for interactions with global regulatory agencies. Its services include support for FDA pathways such as IDE, PMA, 510(k), De Novo, Early Feasibility Studies, and Breakthrough Device Designation, as well as international submissions including CE Mark documentation and country-specific applications. The firm appears to operate as a specialized advisory business rather than a therapeutic product developer, with expertise centered on regulatory affairs, clinical strategy, and commercialization support for device companies.