Dovel Technologies has been awarded the Establishment Evaluation System (EES) Operations and Maintenance contract by the Food and Drug Administration (FDA). The contract, valued at approximately $14 million for five years, will primarily serve customers within FDA’s Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA).
“We are excited to bring our industry-leading health IT and technology capabilities to bear for this mission critical system at the FDA,” said Adam Welsh, Senior Vice President Health IT for Dovel. “We will leverage our experience both with this project and other health domain-specific software systems to ensure the stability and growth of EES.”
EES is important in submitting and tracking Establishment Evaluation Requests (EERs), a required step in the chemistry review process that occurs as part of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Through EERs, the manufacturing process is reviewed with the overall application for marketing new and generic drugs.
Dovèl, as prime contractor, will work to include providing full life-cycle support for system enhancements like updates to the system that augment functionality. Dovel’s partner on this work is PSI International.
