iNGENū CRO

iNGENū CRO is an Australian-headquartered contract research organization specializing in providing full-service clinical trial management and regulatory support for early to mid-stage biotech companies. The company leverages Australia’s R&D tax incentives and rapid regulatory pathways to offer cost-effective, FDA-compliant clinical trials—often reducing costs by up to 70% and accelerating start-up times by over 80%. It has deep expertise in the US FDA pathway, supporting global submissions and approvals for clients primarily from North America. iNGENū has managed over 200 FDA Pre-INDs and more than 50 INDs collectively through its team.