GlobalSubmitCertara
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KnowledgeNETSarjen Systems
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Related Products
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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.
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About
Sarjen's global dossier publishing software is a platform designed to simplify and automate the management and submission of regulatory dossiers. It streamlines the regulatory submission process by automating region-specific and product-specific workflows, which enhances consistency, efficiency, and accuracy. This automation helps to accelerate the creation, validation, and submission of dossiers, reducing manual errors and compliance issues. The solution is built to improve operational efficiency, maintain data consistency, and ensure documentation is audit-ready. By doing so, it saves time and facilitates faster regulatory approvals, ultimately helping to ensure submissions are compliant with various global requirements.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Companies seeking a solution designed to simplify complex regulatory processes
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Audience
Biotech companies
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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API
Offers API
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and VideosNo images available
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Pricing
No information available.
Free Version
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Free Trial
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Pricing
$200
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Company InformationCertara
Founded: 2008
United States
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
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Company InformationSarjen Systems
Founded: 1998
India
www.sarjen.com
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Integrations
No info available.
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Integrations
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