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GlobalSubmit™ PUBLISH

Generate compliant submissions with our advanced eCTD publishing software

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Create health authority compliant eCTD submissions quickly and accurately

GlobalSubmit PUBLISH is a cutting-edge eCTD publishing software that empowers regulatory teams to create and submit compliant eCTD submissions efficiently to health authorities worldwide. Designed with advanced features like live validation, automated hyperlink creation, and accelerated quality control, this software builds quality and efficiency into the eCTD submission process. Whether you’re an experienced publisher or new to regulatory submissions, GlobalSubmit PUBLISH ensures accuracy, compliance, and significant time savings.

9
Number of global health authorities we support - FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan), China, South Africa, and Gulf Coast Council (GCC)
200
Validation error condition checks
9
Submission types supported - IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more

Quality at speed

Efficiency in eCTD publishing is critical as your regulatory department races to meet deadlines and deliver treatments to patients. GlobalSubmit PUBLISH simplifies this process by reducing manual tasks, ensuring compliance, and accelerating workflows. With features like Live Validation, automated PDF processing, and side by side confirmation of bookmark and hyperlink destinations for quality control, this software is a game-changer for regulatory professionals.

Simple, efficient, and transparent

Real-time validation

Live Validation checks for over 200 error conditions, including 40+ PDF checks, ensuring your submissions meet technical requirements and avoid rejection.

Automated PDF processing

Eliminate manual publishing tasks with auto-processed, regulatory-compliant PDFs, saving time and ensuring accuracy.

Accelerated QC process

Reduce QC time by 8X and improve accuracy by 3X, enabling faster and more reliable submissions.

Travel a better road to submission

Powerful but simple review of all your submissions across programs and stakeholders.

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Accelerate the creation of regulatory documents with AI-generated content, freeing up writers for key analysis, messaging, and refinement.

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Increase the speed and quality of your clinical trial submission data with the Pinnacle 21 Clinical Data Management & Automation Suite.

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Why Certara

Certara leads the industry in regulatory science, providing cutting-edge tools and services that empower life sciences organizations to achieve their goals. With GlobalSubmit eCTD Software, you gain access to a best-in-class solution designed to simplify, accelerate, and enhance the submission process.

Our commitment to innovation ensures that you stay ahead of evolving regulatory requirements, while our expertise supports your team at every stage of development. Experience seamless collaboration, reduced risk, and faster approvals with Certara.

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4
Publishing tasks eliminated per document
8
Faster hyperlink and bookmark QC compared with manual methods

PUBLISH in the latest standard

View our webinar series on eCTD 4.0 to understand the new standard and learn how GlobalSubmit is your key to adopting it.

GlobalSubmit eCTD 4.0 webinarsContact us

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Fact Sheet

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On-Demand Webinar

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Your data is safe with GlobalSubmit PUBLISH

Certara’s eCTD software is ISO-certified, ensuring the highest standards of data security and compliance.

Schedule a demo

Discover how GlobalSubmit PUBLISH can streamline your eCTD submission process.

Save time with automated workflows and real-time validation
Ensure compliance with global health authority requirements
Reduce QC time and improve submission accuracy


FAQs

What is eCTD publishing software?

eCTD publishing software simplifies the creation and submission of electronic Common Technical Documents (eCTDs) to regulatory agencies.

Which health authorities are supported by GlobalSubmit PUBLISH?

GlobalSubmit PUBLISH supports submissions to the FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan), China, South Africa, and Gulf Coast Council (GCC).

How does live validation improve submission accuracy?

Live validation identifies and corrects errors in real-time, reducing the risk of technical rejection.

What types of documents does GlobalSubmit PUBLISH Support?

GlobalSubmit PUBLISH supports IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS, and more.