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features
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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

Screenshots View All

Screenshots View All

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

Product Features

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