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What is GlobalSubmit?

Whether you are an experienced expert or just starting out in the realm of regulatory submissions, the threat of rejection for your electronic common technical document (eCTD) submissions is a pressing issue, especially given the growing complexity and continual changes in the regulatory environment. Additionally, the differences in eCTD submission standards across various regions, coupled with the difficulties of overseeing the entire document lifecycle, can hinder your organization’s goals of expediting market access. By leveraging Certara’s GlobalSubmit™ eCTD submissions management software, your regulatory team will gain access to essential resources for effectively publishing, validating, and reviewing eCTD submissions. This method not only helps reduce risks but also allows for a more straightforward eCTD submission workflow, which in turn enables your regulatory team to meet crucial deadlines and deliver treatments to patients efficiently. As your regulatory department continues to work hard under pressure to meet strict timelines and facilitate patient access to innovative therapies, the task of filing eCTD submissions becomes increasingly critical. Thus, it is vital to have appropriate tools and support in place to enhance your submission efficiency, significantly improving your chances of success and ultimately benefiting patient care. Moreover, investing in advanced submission management solutions can lead to smoother operations and better alignment with regulatory demands.

What is Cognition Cockpit?

Cockpit Enterprise is a comprehensive software solution designed for medium to large medical device product developers, combining both requirements management and test management within a unified platform. This application is highly adaptable, allowing customization to align with the specific needs of various organizations. With its robust development environment, Cockpit Enterprise enables companies to implement their Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a controlled and auditable manner. It serves as a vital resource for manufacturers of Class II or III medical devices, facilitating the creation, review, and approval of documentation required for regulatory submissions. Best suited for established companies that already have standard operating procedures in place, Cockpit Enterprise requires sufficient resources for effective system configuration and deployment. Moreover, its user-friendly interface and built-in compliance features make it a preferred choice for businesses aiming to streamline their document management processes.

Media

Media

Integrations Supported

Act!

Integrations Supported

Act!

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Certara

Date Founded

2008

Company Location

United States

Company Website

www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/

Company Facts

Organization Name

Cognition

Date Founded

1995

Company Location

United States

Company Website

cognition.us

Categories and Features

Categories and Features

Requirements Management

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

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