Intelliject’s clinical and regulatory team is composed of experts with decades of experience in both U.S. and global regulatory filings.
The team identifies the appropriate regulatory and clinical pathway to progress each product candidate through to market. Clinical studies are conducted to meet regulatory requirements such as demonstrating a comparable pharmacokinetic profile to an existing therapy. These studies also generate a comprehensive data set that provides meaningful commercial differentiation.
In addition, Intelliject’s human factors program includes several rigorous studies with patients and other users to validate the design of our auto-injectors. This program also contributes to our data generation and dissemination plan. The goals of this plan are to demonstrate to FDA that our pharmaceutical devices are safe, effective and superior to currently available options.