Physician-Sponsored IND

Physician-Sponsored IND is a specialized contract research organization (CRO) and regulatory consultancy that assists individual physicians and academic researchers in navigating the FDA's Investigational New Drug (IND) application process. Founded by experienced biotech executives, the company focuses on 'Sponsor-Investigator' INDs, enabling clinicians to lead their own clinical trials for new indications or novel therapies. Their services include regulatory strategy, protocol development, FDA submission management, and clinical trial oversight. By streamlining the complex regulatory hurdles associated with investigator-initiated research, the firm helps bridge the gap between clinical practice and formal drug development. The company also provides support for expanded access and compassionate use programs, ensuring patients with serious conditions can access experimental treatments.