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What is Veeva Vault RIM?

The Vault RIM Suite provides a robust platform for comprehensive management of regulatory information throughout its entire lifecycle. By consolidating global regulatory workflows within a cloud-based infrastructure, it significantly improves visibility, data integrity, and responsiveness for organizations in the life sciences sector. This centralization enables companies to quickly adjust to evolving regulations while enhancing efficiency during the submission process, from initial planning to final publication. Moreover, the platform fosters seamless collaboration among headquarters, affiliates, and partners, all integrated within a singular RIM system. It ensures that regulatory teams produce content that is trustworthy and maintains the highest standards of data quality. Veeva Vault Registrations manages product registration information globally, including registration status, variations, and interactions with health authorities, while its flexible data model is prepared to integrate IDMP data points and adapt to shifts in regulatory data standards. Additionally, Veeva Vault Submissions streamlines the submission planning process by automating numerous steps in the regulatory workflow, resulting in considerable time savings and enhanced outcomes. This comprehensive approach ultimately empowers companies to navigate the intricate landscape of regulatory compliance with increased ease and accuracy, reinforcing their capacity to succeed in a competitive environment. As regulatory landscapes continue to evolve, this platform positions organizations to stay ahead of the curve.

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.

Media

Media

Integrations Supported

5X
Indent

Integrations Supported

5X
Indent

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

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

Veeva

Company Location

United States

Company Website

www.veeva.com/products/vault-rim/

Company Facts

Organization Name

Certara

Date Founded

2008

Company Location

United States

Company Website

www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/

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