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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 Cruxi?

Cruxi is a dedicated vertical AI platform tailored for teams engaged in the regulatory landscape of medical devices. It adeptly handles a range of resources, such as FDA regulations, guidance documents, product codes, standards, MAUDE events, recalls, and historical 510(k) submissions, to optimize workflows associated with 510(k), De Novo, and eSTAR applications. Users gain the advantage of swiftly classifying devices, assessing predicates, formulating evidence strategies, and creating thoroughly referenced content that meets eSTAR requirements for every component of their submission. The platform not only facilitates comprehensive submission workflows but also includes specialized micro-services like classification, predicate analysis, and drafting particular sections. This adaptability renders Cruxi especially beneficial for early-stage startups, internal regulatory teams, and consultants, allowing them to generate high-quality submissions while significantly reducing manual labor and minimizing unexpected issues with the FDA. By simplifying the regulatory submission journey, Cruxi ultimately assists organizations in effectively navigating the intricate landscape of compliance and ensuring timely market access for their devices. Consequently, this leads to improved efficiency and increased confidence in regulatory processes.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Credit-based system

Supported Platforms

SaaS

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support

Training Options

Documentation Hub
On-Site Training

Training Options

Documentation Hub
Online 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

Cruxi

Date Founded

2024

Company Location

United States

Company Website

cruxi.ai

Categories and Features

Submission Management

Not specified

Categories and Features

Medical Affairs

Not specified

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