GlobalSubmit

GlobalSubmit™ is an eCTD (electronic Common Technical Document) software solution developed by Certara, designed to help regulatory professionals in life sciences organizations publish, validate, review, and transmit regulatory submissions with confidence. Built for teams navigating the complexities of global health authority requirements, GlobalSubmit empowers users to manage the entire submission lifecycle — from new drug applications to updates of existing submissions — with precision, speed, and compliance.

The platform is purpose-built for biotech, pharmaceutical, and CRO organizations that need to eliminate submission errors, accelerate time to market, and maintain compliance with evolving global regulatory standards. GlobalSubmit supports submissions to nine global health authorities, including the FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan), China, South Africa, and the Gulf Coast Council (GCC), and accommodates more than ten submission types including IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS, and EUA.

Core Capabilities

• Comprehensive Publishing Tools: Simplify the creation of submission-ready documents with intuitive, purpose-built publishing tools that support last-minute revisions by publishing only the changed sections.
• Robust Validation Engine: Identify and resolve compliance issues before submission using a live validation engine that enables real-time error detection and correction, reducing the risk of rejection.
• Streamlined Review Process: Conduct in-depth reviews across programs and stakeholders with advanced navigation and annotation features, enabling powerful yet simple review workflows.
• Automated Hyperlink and Bookmark QC: Automatically crosscheck hyperlinks and bookmarks, delivering quality control that is 8x faster and 3x more accurate than traditional manual methods.
• High-Speed Document Processing: Quickly and accurately generate regulatory-compliant PDF documents, process 10 GB of data in minutes, and create up to 1,000,000 hyperlinks per hour.

Key Benefits

• Improved Submission Accuracy: Built-in compliance tools and automated validations ensure error-free submissions, reducing the likelihood of health authority rejection.
• Accelerated Time to Market: Intuitive workflows streamline the submission process, saving time and resources across the regulatory operations team.
• Global Compliance: Continuous software updates reflect the latest regulatory requirements from health authorities worldwide, keeping organizations ahead of changing standards.
• Seamless Team Collaboration: The platform supports multi-stakeholder review and publishing workflows, enabling regulatory teams to work together efficiently across programs.
• Integrated All-in-One Platform: Crosscheck, validation, and publishing are all integrated within a single solution, eliminating the need for separate third-party validation tools.

GlobalSubmit Products and Services

• eCTD Publishing: Create health authority-compliant eCTD submissions quickly and accurately using the core publishing module.
• Submission Review: A powerful but simple review environment for all submissions across programs and stakeholders.
• Regulatory Operations Services: Certara's regulatory operations services complement the software by optimizing processes and ensuring efficiency and compliance throughout the entire submission journey.

eCTD 4.0 Readiness

• GlobalSubmit supports the latest eCTD v4.0 standard, which introduces updated specifications and guidelines for the preparation and submission of electronic regulatory documents.
• Certara has partnered with ANVISA to enable eCTD 4.0 submissions of drug applications in Brazil through GlobalSubmit, advancing ANVISA's digital modernization and streamlining regulatory reviews to accelerate patient access to innovative therapies.

GlobalSubmit is backed by Certara's ISO 27001 certification for its Information Security Management System (ISMS), ensuring robust security controls, rigorous risk assessments, and full compliance with global data protection standards. The software is suitable for small regulatory teams as well as large organizations, offering an integrated, scalable platform that provides confidence at every stage of the submission process.