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What is GlobalSubmit?
Whether you are an experienced expert or just starting out in the realm of regulatory submissions, the threat of rejection for your electronic common technical document (eCTD) submissions is a pressing issue, especially given the growing complexity and continual changes in the regulatory environment. Additionally, the differences in eCTD submission standards across various regions, coupled with the difficulties of overseeing the entire document lifecycle, can hinder your organization’s goals of expediting market access. By leveraging Certara’s GlobalSubmit™ eCTD submissions management software, your regulatory team will gain access to essential resources for effectively publishing, validating, and reviewing eCTD submissions. This method not only helps reduce risks but also allows for a more straightforward eCTD submission workflow, which in turn enables your regulatory team to meet crucial deadlines and deliver treatments to patients efficiently. As your regulatory department continues to work hard under pressure to meet strict timelines and facilitate patient access to innovative therapies, the task of filing eCTD submissions becomes increasingly critical. Thus, it is vital to have appropriate tools and support in place to enhance your submission efficiency, significantly improving your chances of success and ultimately benefiting patient care. Moreover, investing in advanced submission management solutions can lead to smoother operations and better alignment with regulatory demands.
What is BeeCTD?
BeeCTD provides an extensive eCTD management solution specifically designed for pharmaceutical enterprises and regulatory agencies. Its modular framework and straightforward licensing structure empower users to choose the modules they want to employ, including options like Reader, Compiler, and Validator. The sophisticated Reader offers a comprehensive view of the dossier's lifecycle, supporting both eCTD and NeeS sequences while enabling easy conversion between the two formats, including baseline submissions. The real-time sequence validator guarantees adherence to the eCTD/NeeS technical specifications and integrates industry best practices, consistently updating to reflect the latest validation standards, while retaining access to previous versions for reference. Users can effortlessly compile their documents into a compliant eCTD format through our eCTD compiler tool, which can be utilized independently or as a convenient on-demand service where we manage the compilation process for them. Furthermore, the adaptability and scalability of BeeCTD position it as an optimal solution for organizations looking to streamline their regulatory submission workflows, ultimately improving efficiency and accuracy in the process. The system is designed to evolve alongside regulatory requirements, ensuring long-term usability and relevance for its users.
Integrations Supported
Additional information not provided
Integrations Supported
Additional information not provided
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided
Free Version
Free Trial Offered?
Pricing Information
Pricing not provided
Free Version
Free Trial Offered?
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Certara
Date Founded
2008
Company Location
United States
Company Website
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
Company Facts
Organization Name
Altamira
Date Founded
2009
Company Location
Slovakia
Company Website
www.altamira.ai/beectd/