Synchrogenix's GlobalSubmit Submissions Management Suite
Synchrogenix offers the software solutions that regulatory operations professionals need to efficiently publish, validate and review electronic common technical document (eCTD) submissions, plus COMMUNICATE and MANAGE, solutions to tie submissions to the bigger picture of regulatory information management.
When integrated with Synchrogenix's GlobalSubmit Registration Management and Document Management suites, we offer the first truly integrated Regulatory Information Management (RIM) solution for the life sciences industry that supports the real world work habits of regulatory professionals. The fully integrated suite of products allows for informed scheduling and on-time delivery of regulatory submissions to health agencies worldwide.
Design of the Submissions Management suite eliminates a number of manual, time-intensive steps in the regulatory submission process and fortifies the trustworthiness of the data reported by the system.
- GlobalSubmit WebReview - Simplified Submission Review for a Complex Regulatory World
- GlobalSubmit REVIEW - Submissions from the U.S. FDA Point of View
- GlobalSubmit Regulatory Information Management (RIM) System, including
- GlobalSubmit PUBLISH - Efficient PDF Document Publishing and QC
- GlobalSubmit VALIDATE - Eliminate the Risk of Rejection
- GlobalSubmit CROSSCHECK - A Better Way to Verify Bookmarks and Hyperlinks
- GlobalSubmit LINK - Break Free from the Limitations of Adobe Acrobat and Plug-in
In a multi-tenant or public cloud environment, many users are accessing a single instance of a software program running on a server. Here, Synchrogenix's GlobalSubmit Submissions Management Suite is running on shared Amazon Web Services (AWS) infrastructure. Submission data for each company is partitioned into unique, secure buckets within the shared AWS server. These buckets are only accessible with the proper login credentials.
Terms to describe cloud computing for life sciences regulatory publishing are causing some confusion. For the purposes of clarification, Synchrogenix is technically the SaaS software provider while AWS is the provider of the cloud infrastructure hosting the SaaS application.
Clients who elect to purchase a private Secure CLOUD deployment do not share AWS infrastructure with other users. One of the primary benefits of a private deployment is flexibility with regards to timing of software upgrades.
A local installation of Synchrogenix's GlobalSubmit Submissions Management Suite allows for complete control over system upgrades, security and validation. Such an installation would require more internal I.T. resources. Upfront costs and installation time associated with a local installation is greater. Performance, however, is regulated and monitored internally, giving users greater autonomy over the system.