List of Certara GlobalSubmit Customers
Radnor, 19087, PA,
United States
Since 2010, our global team of researchers has been studying Certara GlobalSubmit customers around the world, aggregating massive amounts of data points that form the basis of our forecast assumptions and perhaps the rise and fall of certain vendors and their products on a quarterly basis.
Each quarter our research team identifies companies that have purchased Certara GlobalSubmit for Governance, Risk and Compliance from public (Press Releases, Customer References, Testimonials, Case Studies and Success Stories) and proprietary sources, including the customer size, industry, location, implementation status, partner involvement, LOB Key Stakeholders and related IT decision-makers contact details.
Companies using Certara GlobalSubmit for Governance, Risk and Compliance include: U.S. Food And Drug Administration, a United States based Government organisation with 19116 employees and revenues of $7.20 billion, Anvisa Brazil, a Brazil based Government organisation with 1555 employees and revenues of $180.0 million, Prelude Therapeutics Incorporated, a United States based Life Sciences organisation with 116 employees and revenues of $13.0 million and many others.
Contact us if you need a completed and verified list of companies using Certara GlobalSubmit, including the breakdown by industry (21 Verticals), Geography (Region, Country, State, City), Company Size (Revenue, Employees, Asset) and related IT Decision Makers, Key Stakeholders, business and technology executives responsible for the software purchases.
The Certara GlobalSubmit customer wins are being incorporated in our Enterprise Applications Buyer Insight and Technographics Customer Database which has over 100 data fields that detail company usage of software systems and their digital transformation initiatives. Apps Run The World wants to become your No. 1 technographic data source!
Apply Filters For Customers
| Logo | Customer | Industry | Empl. | Revenue | Country | Vendor | Application | Category | When | SI | Insight |
|---|---|---|---|---|---|---|---|---|---|---|---|
 |
Anvisa Brazil | Government | 1555 | $180M | Brazil | Certara | Certara GlobalSubmit | Governance, Risk and Compliance | 2025 | n/a |
In 2025, ANVISA Brazil partnered with Certara to deploy Certara GlobalSubmit Review and Publish, implementing Certara GlobalSubmit in the Governance, Risk and Compliance category to enable eCTD 4.0 submissions as part of Brazil's regulatory modernization effort. The engagement positions Certara GlobalSubmit to support ANVISA Brazil's intake and handling of electronic dossiers under the new technical standard.
The implementation centered on the GlobalSubmit Review and Publish modules, configured for secure receipt, automated technical validation and dossier lifecycle management of eCTD 4.0 submissions. Functional capabilities implemented include submission intake and validation, structured dossier organization aligned to eCTD 4.0 headings, reviewer assignment and annotation workflows, and controlled publishing and archival of submission packages to support regulatory evaluation.
Operational scope is focused on regulatory submissions in Brazil, enabling ANVISA Brazil to receive and evaluate eCTD 4.0 dossiers through an instrumented submission platform. Governance controls were incorporated consistent with Governance, Risk and Compliance workflows, including audit trails, role based reviewer access, and documented reviewer routing to align submission handling with agency evaluation processes.
|
 |
Prelude Therapeutics Incorporated | Life Sciences | 116 | $13M | United States | Certara | Certara GlobalSubmit | Governance, Risk and Compliance | 2019 | n/a |
In 2019, Prelude Therapeutics Incorporated implemented Certara GlobalSubmit in Governance, Risk and Compliance to publish, validate, and review eCTD regulatory submissions. The Certara GlobalSubmit implementation was targeted at regulatory submission publishing and quality control for United States filings, aligning the application to regulatory operations and eCTD authoring workflows.
Configuration centered on Certara GlobalSubmit PUBLISH, VALIDATE and WebReview, enabling automated validation checks, packaged eCTD sequence creation and web based collaborative review. The deployment emphasized publishing automation and QC gating, consistent with Governance, Risk and Compliance functionality for submission readiness and conformance verification.
Operational scope covered United States regulatory submissions and a small centralized regulatory team within Prelude, shifting QC work from manual document review to system led validation and web review. Business functions impacted included regulatory operations, document control and quality assurance, with GlobalSubmit used as the authoritative publishing and QC tool for submission packages.
Governance and workflow changes included centralized publishing workflows, staged validation gates using VALIDATE, and collaborative WebReview sign off to shorten review cycles. The implementation cut QC from hours to minutes and improved compliance for submission packages.
|
 |
U.S. Food And Drug Administration | Government | 19116 | $7.2B | United States | Certara | Certara GlobalSubmit | Governance, Risk and Compliance | 2005 | n/a |
In 2005, U.S. Food And Drug Administration implemented Certara GlobalSubmit. The FDA has used GlobalSubmit REVIEW and VALIDATE enterprise-wide since 2005 to review and validate new drug and biologics applications across the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The deployment in the United States supports over 6,000 reviewers and provides centralized validation and review functionality.
Certara GlobalSubmit is classified in Governance, Risk and Compliance and is configured to execute document intake validation, automated technical checks, and structured reviewer assignments through its REVIEW and VALIDATE modules. The implementation focuses on ensuring submissions meet technical requirements, enabling rule based validation and reviewer annotation workflows that align with regulatory dossier standards. The full application name Certara GlobalSubmit appears in operational documentation and training used by review teams.
Operational coverage spans CDER and CBER reviewer groups, standardizing review workflows and technical validation criteria across the business functions responsible for new drug and biologics submissions. Governance was established by institutionalizing the application as the enterprise review and validation platform, providing a common source for validation rules and review status tracking. The system provides validation and review functionality to help ensure submissions meet technical requirements.
|
Buyer Intent: Companies Evaluating Certara GlobalSubmit
- Maison Hoggart France, a France based Professional Services organization with 10 Employees
Discover Software Buyers actively Evaluating Enterprise Applications
| Logo | Company | Industry | Employees | Revenue | Country | Evaluated | ||
|---|---|---|---|---|---|---|---|---|
| No data found | ||||||||