Submissions Management

GlobalSubmit’s Submissions Management suite consists of solutions regulatory operations professionals need to efficiently publish, validate and review eCTD submissions, plus MANAGE, a solution to tie submissions to the bigger picture of regulatory information management.

eCTD Submissions Software

The fully integrated suite of products allows for informed scheduling and on-time delivery of regulatory submissions to health agencies. Data from MANAGE’s submission tracking module helps to determine proper allocation of internal resources and real-time regulatory activity status for all of your global products.

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.

When integrated with GlobalSubmit’s Registration Management and Document Management suites, GlobalSubmit offers the first truly integrated regulatory information management solution for the life sciences industry that supports the real world work habits of regulatory professionals.

Deployment Options

Secure CLOUD
Multi-tenant

In a multi-tenant or public cloud environment, many users are accessing a single instance of a software program running on a server. Here, GlobalSubmit’s 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, GlobalSubmit is technically the SaaS software provider while AWS is the provider of the cloud infrastructure hosting the SaaS application.

Single-tenant

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.

Local Installation

A local installation of GlobalSubmit’s Submissions Management Suite allows for complete control over system upgrades, security and validation. Such an installation would require more internal IT 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.