The story of Synchrogenix’s regulatory submissions software solutions starts with REVIEW and VALIDATE, the flagship products that helped usher in the era of eCTD at the U.S. FDA and are still used exclusively by the Agency to evaluate 100% of the electronic submissions it receives.
REVIEW and VALIDATE are now the core components of GlobalSubmit’s Submission Management suite, which also includes our eCTD publishing solution and MANAGE. PUBLISH is a mature product that is now the second most used solution for eCTD publishing. Innovative functionality built into PUBLISH greatly reduces the number of complex, manual steps a user must perform during the eCTD publishing process.
Document Management and Registration Management are the newest additions to GlobalSubmit’s family of products. These product suites bear the hallmarks of our design – simplification of complex regulatory tasks, security compliant with the most stringent standards set forth by the federal government, efficiency and robust processing power.
Integration between our product families gives regulatory teams the option of consolidating operations to a single vendor.
Synchrogenix’s industry leading support is included in the cost of licenses for these products. We also offer a number of product services to streamline implementation including user training, execution/writing of validation scripts and sequence migration.