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ease
features
design
support

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Description

Essenvia enhances business value and improves operational efficiency across various teams and departments. It serves as a centralized hub for all regulatory data, facilitating collaborative document creation and reporting while helping to prevent technical holds, RTAs, and RFIs. This platform empowers the regulatory affairs team to speed up product launches, thus avoiding revenue losses associated with submission delays and missed renewals. It provides a comprehensive overview of the entire regulatory lifecycle, complete with executive dashboards, key performance indicators, and proactive alerts for global registrations, submissions, and change assessments. Essenvia acts as a Regulatory Information Management (RIM) Platform that streamlines regulatory workflows throughout the entire product lifecycle, enabling faster global market access and delivering significant business advantages. By consolidating all regulatory activities into one unified platform, businesses can accelerate their market entry. Additionally, it includes a central repository for all registration documents, which are linked to product master data, allowing users to effectively manage the product registration lifecycle on a country-by-country basis while ensuring compliance and efficiency.

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

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

Integrations

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

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

Essenvia

Country

United States

Website

essenvia.com

Vendor Details

Company Name

Certara

Founded

2008

Country

United States

Website

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

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