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What is KnowledgeNET?

Sarjen's global dossier publishing software acts as a comprehensive platform designed to simplify and automate the management and submission of regulatory dossiers. By optimizing the regulatory submission workflow with automation tailored to various regions and products, it significantly enhances consistency, efficiency, and accuracy. This automation accelerates the processes of dossier creation, validation, and submission while also reducing the risk of manual errors and compliance challenges. Created to boost operational efficiency, the solution guarantees data consistency and ensures that documentation is always prepared for audits. As a result, it conserves valuable time and facilitates faster regulatory approvals, thereby aiding in compliance with a wide range of global standards. Furthermore, the platform boasts an intuitive interface that allows teams to manage submissions more efficiently, which fosters better collaboration and quicker turnaround times, ultimately benefiting the entire regulatory process. This powerful tool is a game changer for organizations looking to navigate the complexities of regulatory compliance effectively.

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.

Media

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Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

$200
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

Sarjen Systems

Date Founded

1998

Company Location

India

Company Website

www.sarjen.com

Company Facts

Organization Name

Certara

Date Founded

2008

Company Location

United States

Company Website

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

Categories and Features

Categories and Features

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