Combination Product Discovery and Development (CPDD)

In-Vitro Biological Testing

At MED Institute, we offer comprehensive support for Combination Product Discovery and Development (CPDD), guiding clients from early concept through regulatory submission and commercialization. Our team is experienced in navigating the complex regulatory landscape for combination products, which often require strategic coordination between device and drug/biologic components. We specialize in preparing and submitting FDA applications—including 510(k), IND, and NDA/BLA submissions—by integrating nonclinical, clinical, and CMC data to meet current regulatory expectations. Our multidisciplinary approach ensures that your combination product development program is aligned with FDA guidance, supports robust design controls, and streamlines the pathway to market clearance or approval.