Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Regardless of whether you are a seasoned professional or a newcomer to the regulatory submission landscape, the possibility of your electronic common technical document (eCTD) submissions being rejected is a significant concern, particularly in light of the increasingly intricate and evolving regulatory landscape. Furthermore, variations in eCTD submission requirements across different regions, along with the challenges of managing the entire document lifecycle, can complicate efforts to achieve your organization’s objectives for speeding up market release. By utilizing Certara’s GlobalSubmit™ eCTD submissions management software, your regulatory team will be equipped with the necessary tools to efficiently publish, validate, and review eCTD submissions. This approach allows you to mitigate risks and sidestep unnecessary complexities through a streamlined eCTD submission process, ultimately supporting your regulatory team as they strive to meet critical deadlines and bring treatments to patients. Therefore, as your regulatory department works diligently to meet tight timelines and ensure timely patient access to new therapies, filing your eCTD submissions becomes an essential task. Ensure that you have the right resources in place to enhance your submission efficiency, thereby bolstering your chances for success.
Description
Sarjen's global dossier publishing software serves as a platform aimed at streamlining and automating the oversight and submission of regulatory dossiers. By enhancing the regulatory submission process through the automation of workflows tailored to specific regions and products, it significantly boosts consistency, efficiency, and precision. This automation not only expedites the creation, validation, and submission of dossiers but also minimizes the likelihood of manual errors and compliance-related issues. Designed to enhance operational efficiency, the solution ensures data consistency and that documentation remains ready for audits. Consequently, it saves valuable time while enabling quicker regulatory approvals, ultimately assisting in meeting diverse global compliance standards. Additionally, the platform's user-friendly interface empowers teams to manage submissions more effectively, leading to improved collaboration and faster turnaround times.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$200
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Certara
Founded
2008
Country
United States
Website
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
Vendor Details
Company Name
Sarjen Systems
Founded
1998
Country
India
Website
www.sarjen.com