The Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 5.203(a). The FDA is contemplating a sole source award under the authority of FAR 6.302-1, with 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. These services are critical to the review functions of the FDA.
