Facet Life Sciences, a leading provider of regulatory strategy and consulting services, today announced it is spinning out its popular Gemstone Electronic Document Management System to an independent company named Kivo with new leadership and investment.

“The decision to spin Gemstone out reflects the potential the product has demonstrated in the market and our desire to empower a dedicated team to realize that potential.” said Facet CEO Ken VanLuvanee. “The spinout will allow the software to be the sole focus of leadership, allowing Kivo to build and expand on Gemstone’s impressive momentum over the past several years.”

Facet Life Sciences, founded in 2012, released Gemstone in 2014 as a novel Electronic Document Management System aimed at emerging life science companies. In the following years, enhancements like Submission Assembly, Collaboration, and Authoring Templates increased customer value and drove Gemstone’s adoption globally.

Kivo leverages the features in the existing products that have proven to reduce publishing times by 30% and has built a brand new platform, that enters beta today, to enable a new generation of collaboration and management tools.

Kivo is led by a new management team, including Toban Zolman as President. Zolman is an industry veteran with a background in scaling early-stage companies. Zolman was an early employee at NJ-based Image Solutions, Inc (ISI), building electronic submission publishing tools before leading product development at FinOps company Cloudability and Commercial IoT leader Rigado.

“There has been shockingly little innovation in the tools available to life science companies over the past decade,” said Zolman, “and smaller companies have few cost-effective options. We are excited to bring collaboration and management concepts that have become commonplace in other industries to life science and enable sponsors to accelerate time to approval.”

Facet and Kivo will maintain a strategic partnership. Facet’s regulatory affairs experts will continue to use Kivo and provide input into Kivo’s product development roadmap.  “Kivo provides the fastest route from document concept to regulatory submission.  It is the foundational piece of technology that permits our regulatory services group to simultaneously manage large numbers of projects with multiple companies,” said Facet Life Sciences COO and Vice President of Research and Development, Lisa Jenkins VanLuvanee, Ph.D. “The new Kivo platform will enable us to do even more for our customers and will enable Kivo’s customers to optimize their own regulated development in ways never possible before.”

About Kivo, Inc.

Kivo creates document and submission management software for life science companies. Kivo Document Management is a Part 11 compliant document repository with ICH and regional templates. Kivo’s Submission Orchestration tools enable submission assembly and management to facilitate regulatory publishing and content tracking across submissions. The platform offers life science companies a comprehensive view of regulatory content.

About Facet Life Sciences, Inc.

Facet Life Sciences is a globally leading provider of expert regulatory strategy and consulting services to smaller and emerging life sciences companies and nonprofit organizations. Facet has led, prepared, and submitted hundreds of FDA applications and acts as the US Agent for over 50 companies.