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GlobalSubmit™

eCTD software to submit with confidence.

Simplify regulatory submissions with GlobalSubmit eCTD Software

Navigating the complexities of electronic Common Technical Document (eCTD) submissions requires precision,efficiency, and collaboration. Certara GlobalSubmit eCTD Software empowers regulatory professionals to publish, validate, and review submissions seamlessly, as a team. By ensuring compliance with global regulatory standards, this advanced software eliminates risks and accelerates your journey to market.

Request a demo Visit our eCTD 4.0 resource center

Comprehensive Publishing Tools: Simplify the creation of submission-ready documents with intuitive tools.

Robust Validation Engine: Identify and resolve compliance issues before submission, reducing rejection risks.

Streamlined Review Process: Conduct in-depth reviews with advanced navigation and annotation features.

Acclerate Regulatory Operations with GlobalSubmit eCTD Software

GlobalSubmit eCTD Software revolutionizes the way life sciences organizations manage regulatory submissions. Designed with a focus on speed, accuracy, and compliance, it provides a seamless platform to support your entire submission lifecycle. Whether preparing for a new drug application or updating an existing submission, the software ensures a smooth and efficient process.

Get started with GlobalSubmit

Improve submission accuracy

Leverage built-in compliance tools and automated validations to ensure error-free submissions.

Accelerate time to market

Streamline the submission process with intuitive workflows that save time and resources.

Ensure global compliance

Stay ahead with continuous updates reflecting the latest regulatory requirements worldwide.

Why choose Certara?

Certara leads the industry in regulatory science, providing leading-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.

Number of global health authorities we support - FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan), China, South Africa, and Gulf Coast Council (GCC)

Submission types supported - IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS, EUA and more

Publish, review, repeat, with ease

Hyperconfidence in your hyperlinks

With automatic crosscheck, quality control (QC) your hyperlinks and bookmarks 8X faster and 3X more accurate than cumbersome, traditional manual methods

Scale and speed

Quickly and accurately generate regulatory compliant PDF documents, process 10 GB of data in minutes, and create 1,000,000 hyperlinks per hour.

Instant fixes

Identify and correct errors in real time, with live validation.

Publish smarter

As you make last-minute changes, only publish the revisions.

GlobalSubmit products and services

Create health authority compliant eCTD submissions quickly and accurately.

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

Certara's regulatory operations services optimize processes, ensuring efficiency and compliance throughout the entire submission journey.

For a small team that has limited time to compile and double check a submission, GlobalSubmit is a really good platform because it is all integrated, including crosscheck and validation features. So, you know when you generate the submission that it is compliant, and you don’t need another tool for validation.

Jessica Pung, MS, RAC
Associate Director of Regulatory Operations, Prelude Therapeutics

Resources

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White Paper

How to Avoid & Fix Common Mistakes in Regulatory Submissions

Learn how to avoid common mistakes so you can streamline your submission process, maximize your chances of success, and navigate the regulatory landscape with confidence.

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On-Demand Webinar

GlobalSubmit 4.0 Webinars

The world of electronic regulatory submissions is about to change with the introduction of eCTD (Electronic Common Technical Document) v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents.

Watch now

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Case Study

Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara’s GlobalSubmit eCTD Software

Your data is safe with GlobalSubmit eCTD Software

Your data is safe with GlobalSubmit eCTD Software. Certara is ISO-certified, ensuring that your sensitive regulatory information is protected with the highest standards of security and compliance.

Schedule a demo of GlobalSubmit eCTD Software

Experience the power of GlobalSubmit eCTD Software in action. Schedule a demo to see how it can revolutionize your submission process, enhance compliance, and reduce risks.

Why request a demo?

Explore intuitive workflows and advanced features in real-time.

Learn how the software ensures global compliance and error-free submissions.

See how automation can accelerate your time to market.