Press Releases

Extedo and Veeva Integrate to Deliver Regulatory Submissions Management from Content Creation to Publication

Integration gives customers a new option for moving their regulatory content into the cloud to streamline collaboration and the submissions process

Munich/ Ottobrunn, Germany – May 14, 2013: With the integration of EXTEDO’s eCTDmanager to Veeva Vault, customers will have a reliable cloud-based solution for publishing submissions to health authorities around the world. Veeva Vault Submissions is a cloud application that manages content for regulatory submissions and promises to take pain out of the submissions process by orchestrating how internal and external collaborators contribute documents during the development process.

“With Vault Submissions, life sciences teams can access and contribute content from any browser anytime, anywhere. Real-time reporting and insights allow companies to proactively manage their submissions,” says Jen Goldsmith, vice president of Veeva Vault. “With the integration of EXTEDO’s easy-to-use publishing tool, sponsors or local affiliates anywhere in the world can deploy a comprehensive solution.”

EXTEDO’s eCTDmanager is an off-the-shelf electronic submission management solution that satisfies requirements for eCTD and non-eCTD submissions, electronic or paper. Users can build and review submissions, add, edit and delete elements or even set hyperlinks and comments at any time during the submission compilation. Documents can easily be moved, imported and referenced from Vault Submissions.

“There is a clear trend in the life sciences industry toward using cloud-based solutions to manage regulated processes and content”, says Christian Bohrmann, Vice President Marketing & Alliances at EXTEDO. “With the integration of Vault Submissions and eCTDmanager customers get easy access and collaboration married with end-to-end submissions management.”

About EXTEDO

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management.

EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.

Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare and public sector.

For more information visit www.extedo.com.

About Veeva Systems

Veeva Systems is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence and customer success, Veeva has over 150 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Founded in 2007, Veeva is a privately held company headquartered in the San Francisco Bay Area, with offices in Philadelphia, Barcelona, Budapest, London, Paris, Beijing, Shanghai and Tokyo. For more information, visit www.veevasystems.com.

Media Contacts

Veeva Systems, Inc.
pr@veeva.com

Thomas Kessler
EXTEDO GmbH
+ 49 89 189 454 222
kessler@extedo.com

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