GlobalSubmit™ PUBLISH: Simplifying Global eCTD Submissions from One Platform

For regulatory affairs professionals, the challenge of managing eCTD publishing and submissions across multiple health authorities is anything but simple. Every region carries its own standards, timelines, and technical requirements, and the cost of a rejected submission goes far beyond wasted effort. It means delayed treatments, missed deadlines, and additional cycles of rework. GlobalSubmit™ PUBLISH, developed by Certara, was built with exactly this reality in mind: a purpose-built eCTD publishing solution that enables teams to create, validate, and submit compliant dossiers to health authorities around the world, from a single, unified platform.

This post breaks down which global regions GlobalSubmit PUBLISH supports, what makes each submission unique, and how the platform’s capabilities directly benefit your regulatory team.

Supported regions: A truly global footprint

GlobalSubmit PUBLISH supports submissions to ten major health authorities, covering the most critical pharmaceutical markets in the world:

FDA (United States)

The U.S. Food and Drug Administration is one of the world’s most rigorous regulatory bodies. GlobalSubmit PUBLISH supports eCTD 3.2.2 and the newly adopted eCTD 4.0 standard, one of the first submission software solutions to do so following the FDA’s transition. Submission types supported include INDs, NDAs, ANDAs, sNDAs, BLAs, and DMFs.

EMA (European Union)

The European Medicines Agency oversees marketing authorization across EU member states. GlobalSubmit PUBLISH supports MAA and ASMF submission types, with built-in compliance for EMA-specific technical requirements and eCTD 3.2.2 standards.

While the EMA mandates eCTD for centralized marketing authorization applications, Non-eCTD Electronic Submissions (NeeS) remain an accepted format for certain EU national, decentralized, and mutual recognition procedures. GlobalSubmit PUBLISH supports NeeS submissions, enabling teams managing EU national procedure applications to work within a single platform rather than maintaining separate tools and workflows for different submission formats. This is particularly valuable for organizations managing both centralized and national-route products across the EU simultaneously.

加拿大卫生部

Canada’s federal health authority requires NDS submissions that follow distinct regional guidance. GlobalSubmit PUBLISH handles these requirements natively, ensuring your dossiers are structured and formatted correctly for Health Canada review.

Swissmedic (Switzerland)

Switzerland maintains its own regulatory pathway outside of the EU framework. GlobalSubmit PUBLISH accommodates Swissmedic-specific requirements, enabling submissions to this often-overlooked but commercially significant market.

TGA (Australia)

The Therapeutic Goods Administration in Australia follows eCTD conventions with region-specific nuances. GlobalSubmit PUBLISH ensures your Australian submissions meet TGA expectations without requiring a separate workflow or toolset.

PMDA (Japan)

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has unique and highly structured submission requirements. GlobalSubmit PUBLISH provides structural and validation support tailored to PMDA’s submission requirements.

China (NMPA)

China’s National Medical Products Administration is a rapidly evolving market with growing eCTD adoption. GlobalSubmit PUBLISH supports submissions aligned with NMPA’s current technical standards, positioning your team to capitalize on this major market.

South Africa (MCC/SAHPRA)

The South African Health Products Regulatory Authority represents an important emerging market. GlobalSubmit PUBLISH’s support for SAHPRA expands your global reach beyond traditional tier-one markets.

Gulf Cooperation Council (GCC)

The GCC encompasses six Gulf nations: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the UAE. A single GCC submission can unlock access to all six markets simultaneously, and GlobalSubmit PUBLISH is designed to support this multi-country regional framework.

Brazil (ANVISA), NeeS

Brazil’s National Health Surveillance Agency (ANVISA) currently accepts Non-eCTD Electronic Submissions (NeeS) for drug applications, and GlobalSubmit PUBLISH supports this format natively. As Latin America’s largest pharmaceutical market, Brazil represents a strategically significant opportunity. NeeS submissions follow the familiar CTD folder structure with a hyperlinked PDF Table of Contents, making them manageable within the same GlobalSubmit workflow your team already uses for other regions. Looking ahead, Certara and ANVISA announced a formal partnership in November 2025 to implement eCTD 4.0 submissions through GlobalSubmit, positioning Brazil to align with ICH global standards. GlobalSubmit PUBLISH is actively working toward full eCTD 4.0 support for Brazil, meaning your team will be able to transition seamlessly when that standard goes live, without switching platforms.

Key benefits for regulatory affairs professionals

Supporting nine health authorities is impressive, but the real value of GlobalSubmit PUBLISH lies in how it makes that global reach operationally practical for your team.

Live validation to prevent rejection before it happens

GlobalSubmit PUBLISH performs live validation as you work, flagging structural errors, broken hyperlinks, and non-compliant elements in real time, before you submit. This drastically reduces the risk of technical rejection and eliminates time-consuming post-publish QC cycles.

Automated hyperlink creation

Manually creating and verifying hyperlinks across a large dossier is one of the most error-prone and time-intensive tasks in eCTD publishing. GlobalSubmit PUBLISH automates this process, generating compliant links accurately and consistently, cutting hours of manual effort per submission.

Accelerated quality control

The platform’s automatic CrossCheck feature QCs hyperlinks and bookmarks up to 8x faster and 3x more accurately than traditional manual methods. For teams under deadline pressure, this translates directly into faster, higher-confidence submissions.

Incremental publishing for last-minute changes

When last-minute document changes are unavoidable, GlobalSubmit PUBLISH allows you to publish only the revised sections rather than regenerating the entire submission. This preserves your timeline and reduces risk when changes happen close to submission deadlines.

Automatic compliant PDF generation

The platform can automatically generate health authority-compliant PDF documents, removing at least four manual publishing tasks per document. For regulatory teams working with large document sets, this automation is a substantial time saver.

eCTD 4.0 ready

With regulatory authorities actively transitioning to the eCTD 4.0 standard, GlobalSubmit PUBLISH is already ahead of the curve. Developed with direct input from the FDA, the platform ensures your team can adopt the new standard without disruption to existing workflows.

Built for teams of all sizes and experience levels

Whether you are an experienced publisher or new to eCTD submissions, GlobalSubmit PUBLISH is designed to guide users through a compliant workflow. Onboarding includes installation guides, manual practice documents, and personalized Q&A sessions, ensuring your team is productive from day one.

A platform built around your submission deadlines

The regulatory landscape is growing more complex, not less. With evolving standards, expanding global markets, and mounting pressure to accelerate time to approval, regulatory affairs teams need tools that keep pace, not tools that create additional overhead.

GlobalSubmit PUBLISH brings together global health authority support, intelligent automation, and built-in validation into a single platform that reduces risk and helps your team move faster at every stage of the submission process. Backed by more than 15 years of industry experience, it is a platform with a proven track record at some of the world’s leading pharmaceutical and biotech organizations.

Ready to Simplify Your Global Submissions?

Whether you are expanding into new markets or looking to improve efficiency in your existing submission workflows, GlobalSubmit PUBLISH can help. See why leading life sciences companies trust Certara to get their submissions right, the first time.

Contact us to learn how GlobalSubmit PUBLISH can support your regulatory workflows.