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GlobalSubmit™ REVIEW

Fast, simple, and easy eCTD reviews

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Simplified eCTD submission review for a complex regulatory world

GlobalSubmit REVIEW is a cutting-edge eCTD viewer designed to simplify and accelerate the regulatory submission review process. Regulatory professionals face immense challenges in ensuring timely and accurate eCTD submissions, often involving multiple stakeholders and complex approval workflows. GlobalSubmit REVIEW addresses these challenges by providing a streamlined, cloud-based platform that ensures compliance, reduces delays, and enhances collaboration. With its intuitive interface and robust capabilities, GlobalSubmit REVIEW empowers teams to confidently manage health authority-compliant eCTD submissions.

Streamline the eCTD review process, anytime and anywhere

GlobalSubmit REVIEW is purpose-built to meet the demands of a complex regulatory environment. By enabling seamless collaboration across stakeholders, this eCTD viewer ensures that your global submissions are reviewed efficiently and accurately. Whether managing investigational or marketing applications, GlobalSubmit REVIEW provides the tools needed to navigate the submission process with confidence.

  • Supports a wide range of submission types, including IND, NDA, sNDA, ANDA, BLA, MAA, DMF, ASMF, NDS and more
  • Fully compliant with 21 CFR Part 11 regulations
  • Seamless integration with leading electronic document management systems (eDMS)
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6
Number of global health authorities we support - FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan)
9
Submission types supported - IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more
200
Error conditions utilized, including 40+ PDF checks
50%
Faster to load submissions, reducing wait time

Fast, simple, and easy eCTD reviews

Streamlined review process

GlobalSubmit REVIEW simplifies the eCTD review process by providing a user-friendly interface and advanced tools that reduce the risk of errors and delays.

Cloud-based accessibility

Access your eCTD submissions anytime, anywhere with a secure, cloud-based platform, reducing IT overhead.

Regulatory compliance

Ensure compliance with health authority standards, including 21 CFR Part 11, with every submission.

Travel a better road to submission

Create health authority compliant eCTD submissions quickly and accurately.

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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.

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1.5m
The number of regulatory submissions managed with GlobalSubmit
On-Demand Webinar
GlobalSubmit REVIEW and you: how to expedite the submission review process

Have you ever wondered how you could speed up the submission review process without compromising quality? Join us to learn more about the time-saving features of GlobalSubmit Review, such as Crosscheck, live validation, and more. We will explore these features as well as discuss how they can add efficiencies to your submission process.

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Related resources

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Blog

Best Practices for a Successful eCTD Submission

Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best practices for addressing them.
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On-Demand Webinar

RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes

Oops, I made a mistake! Everyone has made or seen one, and sometimes it is embarrassing to discuss. This webinar will examine common administrative and technical mistakes, errors, and omissions...
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Our experts compiled the tips and best practices you need to know for a successful eCTD submission.
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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.
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10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

In this blog post, we explore the top 10 things you need to know about eCTD 4.0, and its potential benefits for the pharmaceutical industry.
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Your data is safe with GlobalSubmit REVIEW

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

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Discover how GlobalSubmit REVIEW can streamline your eCTD submission review process.

Simplify collaboration across stakeholders
Ensure compliance with health authority standards
Reduce delays and enhance submission accuracy


FAQs

What types of submissions does GlobalSubmit REVIEW support?

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

Is GlobalSubmit REVIEW compliant with 21 CFR Part 11?

Yes, GlobalSubmit REVIEW is fully compliant with 21 CFR Part 11 regulations.

Can GlobalSubmit REVIEW integrate with my existing eDMS?

Absolutely, GlobalSubmit REVIEW seamlessly integrates with leading electronic document management systems (eDMS).

Is GlobalSubmit REVIEW cloud-based?

Yes, GlobalSubmit REVIEW is web-hosted, so no installation is required, and it is compatible with all operating systems and browsers.