FDA’s Office of Business Informatics (OBI) supports the Center for Drug Evaluation and Research (CDER’s) regulatory decision-making by identifying, implementing, and managing CDER-wide informatic systems to meet business needs.
Gunnison provides end-to-end business analysis and testing services to support OBI’s mission. Our testing services include functional and web services automation for a suite of complex integrated systems. Gunnison is also responsible for managing OBI’s Automation Testing Center of Excellence.
Gunnison played an important role at the beginning of the COVID-19 pandemic, as we provided quality assurance and end-to-end analysis and testing support for the Alternate Submissions System that expedited the application process for COVID-19 treatment submissions and COVID-19 Critical Care Drug Monitoring Survey Portal for use by hospitals and organizations to submit frequent drug demand surveys for COVID-19.
As a result of the excellent work Gunnison has delivered to FDA, the company continues to be engaged with FDA under a new 3-year follow-on contract.