GlobalSubmit is dedicated to facilitating regulatory submissions between life sciences companies and global regulatory agencies. Our flagship Submissions Management Suite includes solutions for publishing, validating and reviewing eCTD submissions, as well as submission tracking and monitoring regulatory activity status. We have also introduced solutions for life sciences document management and regulatory information management.
We also offer a host of regulatory services including, but not limited to, regulatory publishing, regulatory operations and affairs consulting, data services, migration, medical writing, US Agent service and ESG transmission.
Since 2005, GlobalSubmit has been the U.S. Food & Drug Administration’s sole eCTD software vendor. The FDA relies exclusively on GlobalSubmit’s REVIEW™ and VALIDATE™ platforms to evaluate the technical validity of 100% of the electronic submissions it receives.