Veeva Systems Inc.

Rolando Sa

Uri Reich

Richard Merrick

Katharyn Wilber

Sandra Komadinic

Hong Fai Chan

Systems and methods for managing regulatory information. The system comprises a submission controller, a registration controller and a submission archive controller. The submission controller may manage a submission structure, and allow users to search for documents in a content management system and add the documents to the submission structure. The registration controller may manage product registration information and health authority interactions globally, and capture, view and take actions upon product registrations. The submission archive controller may allow users to access a complete history of regulatory submissions and correspondence globally, with an easy to use interface. The three controllers reside in a single system that allows them to interact seamlessly with each other.

System and method for managing regulatory information

Systems and methods for submitting regulatory documents, from authoring through uploading to a health authority gateway. It may continuously publish documents into a submission archive as documents become associated to the content plan and as related content or attributes are updated. It may continuously validate submission components by applying validation rules defined by a health authority to report non-conforming validation results during the publishing process. It may allow users to review and resolve validation errors and warnings by reporting information to users on an ongoing basis to help reduce end-stage reconciliation.

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Lebanon, NJ, United States of America

Rolando Sa