Leading Japanese pharmaceutical company standardizes on Vault Submissions and Vault
Submissions Archive to speed submission development and health authority correspondence
PLEASANTON, CA — June 25, 2019 — Veeva Systems (NYSE: VEEV) today announced that Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura; hereinafter “Sumitomo Dainippon Pharma”) implemented Vault Submissions and Vault Submissions Archive last year to unify its regulatory submissions processes. As part of the Vault RIM Suite, Vault Submissions and Vault Submissions Archive give Sumitomo Dainippon Pharma a single authoritative source for submission development and enable the company to respond faster to health authority requests.
“Veeva gives us the best technology platform to streamline submissions and improve visibility into global regulatory processes,” said Kenichi Otani, senior director, development regulatory affairs, drug development division, at Sumitomo Dainippon Pharma. “Veeva Vault Submissions and Veeva Vault Submissions Archive help simplify processes and increase collaboration, while making our correspondence with health authorities more efficient.”
Sumitomo Dainippon Pharma previously had a mix of systems to manage regulatory submissions. Since unifying on Veeva Vault RIM applications, Sumitomo Dainippon Pharma gained a single source of truth for all submission activities, from planning to authoring to archiving. This allows the company to have greater access and control over regulatory submissions worldwide.
With actionable reports and dashboards in Vault Submissions, Sumitomo Dainippon Pharma can closely track the progress of submission content as well as the overall status of each submission. Vault Submissions supports all major filing types and country-specific modifications. With Vault Submissions Archive, the company can easily locate the complete history of regulatory submissions, facilitating faster and more accurate interactions with local health authorities.
“The Veeva Vault RIM Suite enables pharmaceutical companies to drive greater efficiency throughout their regulatory operations,” said Takashi Okamura, general manager of Veeva Japan. “We are honored to work with Sumitomo Dainippon Pharma to harmonize its global submissions processes.”
The Vault RIM Suite provides fully integrated RIM capabilities to manage product registrations, health authority correspondence and commitments, submissions documents, and published dossiers on a single cloud platform. Vault RIM is part of Veeva Development Cloud, a unified suite of applications for clinical, regulatory, quality, and safety to help organizations drive end-to-end business processes across product development. Learn more at veeva.com/DevelopmentCloud.
For more on Veeva Vault RIM Suite, visit: veeva.com/RIM
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About Sumitomo Dainippon Pharma
Sumitomo Dainippon Pharma operates every day to achieve its corporate mission “to broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.” By pouring all efforts into the research and development of new drugs, Sumitomo Dainippon Pharma aims to provide innovative and valuable pharmaceutical solutions to people not only in Japan but also around the world in order to realize its corporate mission. Sumitomo Dainippon Pharma’s goal is to create innovative pharmaceutical products. Psychiatry & Neurology, Oncology as well as regenerative medicine/cell therapy represent its focus therapeutic areas containing significant unmet medical needs. For more information, visit www.ds-pharma.com.
About Veeva Systems
Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 750 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.
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