Veeva Submissions

Overview

Veeva Submissions is a content management application designed to streamline the process of planning, authoring, reviewing, and approving regulatory documents. It offers comprehensive enterprise content management features, including creation, version control, and real-time co-authoring for all documents involved in submissions.

Key capabilities include content planning, enabling users to draft an outline for submissions and automatic document matching to this outline. The application supports the construction and publication of both clinical and non-clinical reports using Report Level Content Plans.

Features

• Real-time dashboards and reports for tracking document status.
• Automation of authoring and assembly tasks to speed up the time to market.
• Facilitates coordination of global teams for consistent affiliate submissions and interactions with health authorities.

The tool has been used successfully since 2013 and is considered very mature, with over 100 customers including top biopharma companies. Veeva Submissions serves as a single authoritative source that consolidates IT systems and significantly reduces the need for written standards by 90%.

Customer Impact

Testimonies from industry leaders at companies like Eli Lilly, Cerevel, and Roche emphasize improvement in regulatory submission processes, ease of use in system management, and comprehensive integration of data, content, and processes.