First-to-market: Leveraging PMDx Integrated Solutions
You qualified a biomarker that will benefit the healthcare of patients worldwide. Do you have the resources to validate and move to market before your competitors do?
A growing biotech was struggling to meet resource and logistical requirements for an upcoming Premarketing Application (PMA) for FDA submission. While raw materials and resources were available, the organization lacked the time, capital, and infrastructure required to meet their goals.
ProMedDx engineered a suite of bioservices, customizing its proprietary systems into a fully-integrated solution for the client. This enabled the organization to maintain their focus on collecting data and preparing for submission. As a result, they ultimately gained FDA approval 12 months ahead of schedule and achieved first-to-market status. Furthermore, they avoided the capital burden of additional staff, process development, equipment, and software.
Download the full case study here to learn how one company completed its PMA 12 months ahead of schedule by leveraging ProMedDx Biospecimen Solutions.