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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
Software for submission management that simplifies application management, data analysis, and compliance. You can quickly create complex forms and get the media and data you need in the format that you prefer. Our expert support team can help you create complex or simple workflows. You can evaluate effectively using features like auto-tag and auto-score, self-reject, user score. Use the in-app mail to communicate directly with candidates. Use powerful analytics tools to create meaningful reports that you can control.
API Access
Has API
API Access
Has API
Integrations
Microsoft Excel
Stripe
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$995.00/year
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
Certara
Founded
2008
Country
United States
Website
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
Vendor Details
Company Name
Submit.com
Founded
2013
Country
Ireland
Website
www.submit.com
Product Features
Product Features
Contest
Awards Management
Blind Judging
Entrant Management
Entry Fee Processing
Entry Management
Forms Management
Fraud Detection
Judging Management
Scoring
Skills Contests (Photo, Essay, Design, etc)
Social Media Management
Social Promotions
Sweepstakes
Timeline Management
Voting Management
Forms Automation
Approval Process Control
Archiving & Retention
Collaboration
Document Indexing
Drag & Drop
Full Text Search
Remote Document Access
Rules-Based Workflow
Text Editing
Version Control
Grant Management
Compliance Management
Contract Management
Grant Application Management
Grant Award Tracking
Grant Opportunity Search
Self-Registration