FDA has issued notice that it is contemplating a sole source award to SYNCHROGENIX INFORMATION STRATEGIES, LLC to maintain continuity of operations for the FDA Legacy Electronic Common Technical Document (eCTD) Licenses, Maintenance and Support for GlobalSubmit Review and GlobalSubmit Validate.
In this context, “lights on” maintenance and support of the GlobalSubmit software product includes problem resolution, technical discussions, minor system enhancements necessitated by regulatory requirements or mandates to meet FDA requirements.
