GlobalSubmit

GlobalSubmit

Certara
+
+

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About

Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire document lifecycle and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions.

About

Predict genotoxic & carcinogenic endpoints of impurities and degradants to meet ICH M7 guidelines. Impurity Profiling Suite can be used as part of your ICH M7 workflow—to help prepare regulatory submissions and remain compliant.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Companies seeking a solution designed to simplify complex regulatory processes

Audience

Chemists

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Certara
Founded: 2008
United States
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/

Company Information

ACD/Labs
Founded: 1994
Canada
www.acdlabs.com/products/percepta-platform/impurity-profiling-suite/

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Categories

Categories

Integrations

No info available.

Integrations

No info available.
Claim GlobalSubmit and update features and information
Claim GlobalSubmit and update features and information
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Claim Impurity Profiling Suite and update features and information