Veeva rolls out cloud application to accelerate regulatory submission delivery

The addition of Vault Submissions Publishing unifies publishing capabilities and enterprise content management to streamline end-to-end submission development. Now life sciences companies can plan, review, publish, archive, and validate submissions within a single cloud platform.

Traditionally, regulatory submissions are created with disparate systems for content management and publishing. Working with separate systems requires file transfers and impedes the publishing team’s visibility into document readiness, making it difficult to effectively plan and allocate resources.

Gens and Associates managing partner Steve Gens, said: “Submission planning, registration tracking, document management, and publishing are all within one end-to-end process.

“Having publishing within a set of unified regulatory capabilities can reduce cycle times and improve productivity throughout the entire submission development process.”

Veeva Vault Submissions Publishing empowers publishing teams to perform activities during document authoring, formatting, and reviews. This enables a continuous publishing process instead of waiting for the submission plan and documents to be finalized.

With activities such as document hyperlinking and validation now moved upstream and automated, teams can complete work faster and speed submission development.

The Medicines Company vice president, regulatory operations global head Frank Bosley said: “The industry struggles with disjointed systems that force regulatory teams to duplicate data, documents, and effort.

“A unified RIM approach like Veeva's can streamline submission preparation and enable sponsors to reduce risk and delays.”

Veeva Vault Submissions Publishing together with Vault Registrations, Vault Submissions, and Vault Submissions Archive delivers a unified RIM suite for seamless information and traceability throughout RIM processes.

Veeva Veeva Vault RIM vice president John Lawrie said: “RIM transformation is gaining considerable momentum as companies seek greater visibility and global alignment across regulatory.

“Now, with end-to-end submission development, regulatory can speed submission delivery and gain complete traceability between source documents, filed dossiers, and related product registrations.”

Veeva Vault Submissions Publishing is planned for availability in early 2018.