New Capability in Vault PromoMats to Speed Packaging Promotional Materials for FDA Submission
Veeva Systems (NYSE: VEEV) today announced at Veeva Summit Online a new capability in Veeva Vault PromoMats to speed the digital submission of promotional materials for accelerated approval products. Vault PromoMats will automatically generate submission-ready forms to simplify packaging promotional materials to send via eCTD (Electronic Common Technical Document) to the U.S. Food and Drug Administration (FDA). Brand marketing teams can reduce time in preparing content in a compliant digital format and getting it ready for FDA submissions.
“Veeva is helping life sciences stay ahead of evolving regulations and accelerate the shift toward digital,” said Pooja Ojala, vice president of commercial content at Veeva. “Veeva Vault PromoMats will allow brand marketing teams to create digital submissions faster and easier, while maintaining compliance with federal requirements.”
Last year the FDA finalized guidance on electronic submission via eCTD for postmarketing and accelerated approval products. Veeva is enabling customers to meet the FDA’s fast-approaching June 2021 deadline that will make it mandatory to submit promotional materials electronically.
Vault PromoMats automates preparing submission-ready content to make it faster and easier for brand marketing teams to package websites, emails, and other content for FDA review. Automatic linking of promotional materials and references simplifies building a package consistent with eCTD data requirements. Templatized forms allow customers to create a binder of relevant documents in the right structure and naming format for faster health authority submission.
In other news today, Veeva announced Veeva Link for KAM, a new solution that gives commercial and medical teams accurate customer data and real-time insights for key account management. Read today’s press release to learn more.
Vault PromoMats is an advanced application that combines digital asset management with medical, legal, and regulatory review to improve global reuse of promotional materials and maintain compliance from content creation through distribution. The new capability to generate submission-ready forms for accelerated approval products is planned for availability in December 2020.
Learn how Vault PromoMats allows brand marketing teams to reduce time and errors when creating digital submissions at Veeva Summit Online, 9-10 June. The event is only open to life sciences industry professionals. Register for the virtual event and on-demand sessions at veeva.com/Summit.
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 875 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/eu.
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions (including the on-going impact of COVID-19), particularly within the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-Q for the period ended April 30, 2020. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.
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