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Description
Automated automation streamlines the application process, and eliminates paperwork. Connect and organize your operations. EDvera is used by government agencies and accreditors to reduce operating costs and save time. Accessible online on any smart device or computer, without the need for any software or apps. Standardizes and organizes processes to reduce errors and increase productivity. Future-proofed and flexible enough to meet your organization's needs. You can connect your staff to their work, from the initial application through payment processing and annual reporting. You can save, update and share documents with comments during the submission process. Electronic document submission and management can simplify team workflows. The system tracks all changes to documents and creates an audit trail.
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.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
EDvera
Country
United States
Website
edvera.com
Vendor Details
Company Name
Certara
Founded
2008
Country
United States
Website
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
Product Features
Accreditation Management
Collaboration
Compliance Management
Document Management
Higher Education
Requirements Management
Reviewer Portal
Self Assessment
User Access Permissions
Workflow Management