Effortlessly Compliant: Vault PromoMats Already Ensures eCTD Readiness

Life sciences companies will soon be required to submit promotional materials electronically to the U.S. Food and Drug Administration, according to FDA guidance issued earlier this year. But the time to act is now. As of June 15, 2015, the FDA has opened its doors to accepting electronic submissions.

The move to digital, rather than paper, submissions is an important sea change. The risks and inefficiencies associated with sending CDs—or worse, stacks of paper documents—down to the FDA will soon disappear. For companies with an upcoming product launch, submitting promotional materials digitally now will eliminate the need to switch submission formats midstream.

Many life sciences companies are responding to these new regulations by investing in an electronic promotional content management system, which keeps them ahead of the next requirement and ready to share, update, track and submit all promotional materials in a compliant digital format.

At Veeva, we readied our customers for these industry changes some time ago, and can help companies make a smooth transition to these new regulations. With Vault PromoMats users can automatically generate submission-ready forms and create a bulk package consistent with the latest eCTD data requirements.

To further facilitate electronic submission, Veeva has partnered with leading publishing providersto establish integrations between our solution.

As life sciences companies are readying for eCTD, many are taking the opportunity to invest in systems that stay ahead of evolving regulations and don’t prompt a new software upgrade every time the rules change. This is a key benefit of multitenant cloud solutions, which simply deliver new innovations to all users faster, typically at least three times per year, without the added cost or delay of upgrades. A great example is Veeva Vault, where users are already performing digital FDA submissions today—proof of the benefits of this rapid innovation and delivery.

Talk to us about how Vault PromoMats can help your business leverage the efficiency of the new eCTD guidelines and keep you in compliance, effortlessly. Learn more.