Dovel Technologies Awarded FDA Contract for Establishment Evaluation System
Company will help maintain and update system critical to ensuring the availability of safe and effective drugs.
McLean, VA September 25, 2012 – Dovel Technologies announced today they have been awarded the Establishment Evaluation System (EES) Operations and Maintenance contract by the Food and Drug Administration (FDA). The contract primarily serves customers within FDA’s Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA).
EES is an integral element of the FDA’s drug application review process. The system is used to submit and track 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 in conjunction with the overall application for marketing new and generic drugs.
As Prime contractor, Dovel will ensure system availability, maintain existing EES functionality, and provide FDA the flexibility to enhance the system’s functionality. Dovèl’s work will include providing full life-cycle support for system enhancements including updates to the system that augment functionality.
“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.
The contract is valued at approximately $14M for five years. Dovel’s partner on this work is PSI International.