Moonbay Technology Launches Company and First Product, PIPELINE EDMTM, at the 2009 DIA Annual Meeting
SaaS-based PIPELINE EDM provides regulatory document management and electronic submissions with low IT overhead
San Diego, CA - June 18, 2009 - Moonbay Technology announces its launch into the life sciences industry with its first product, PIPELINE EDMTM, a regulatory document management and electronic submission system. PIPELINE EDM is based on SaaS Technology that dramatically saves time and money for companies already strapped for resources and provides users with a comprehensive web interface.
Built from the ground up with Regulatory Affairs in mind, Moonbay Technology thoroughly understands drug development. Workflows have been meticulously designed for companies with products in drug development and commercialization.
PIPELINE EDM complies with 21 CFR Part 11 requirements and covers regulatory document management, e-publishing, compliance, and clinical management. Modules include Research, Nonclinical, Clinical, Safety, Quality, Chemistry Manufacturing and Controls (CMC), and Regulatory Affairs. PIPELINE EDM transforms your documents to be submission-ready providing significant time and operational efficiency that can save months of labor-intensive compilation.
"PIPELINE EDM reduces the total cost of system ownership as the only IT requirements are an internet connection and a browser. Moonbay Technology also understands the financial positions of many emerging life-science companies by offering subscription-based pricing," said Jill Iacopi, Founder and CEO of Moonbay Technology.
A pharmaceutical start up in the San Francisco Bay area uses PIPELINE EDM as its Document Management System for their regulatory submissions and associated documents. Their Director, Regulatory Affairs, mentioned, "We have found PIPELINE EDM easy to use, highly effective and a great help for document editing and review. Moonbay Technology has been extremely helpful with tailoring the system to our particular needs and with any questions we have had."
Summary
Emerging life-science companies are experiencing increased pressure as regulatory agencies push for electronic submissions. Agencies also expect compliant information to be collected during drug development, including data from clinical trials, manufacturing and quality systems.
Robust software solutions are needed to meet the expectations of the regulatory agencies. But it is unrealistic to expect an IT department with limited resources to customize, configure, install, maintain and validate every software application that the company purchases. PIPELINE EDM lifts the support burden and cost from IT.
About Moonbay Technology
Moonbay Technology provides regulatory document management applications and services that help life science companies with efficiency, due diligence and compliance. And we do it more cost effectively than other companies because our products are based on the Software-as-a-Service (SaaS) model, and relieves organizations from the time and resource drain on IT management and infrastructure.
For more information visit www.moonbaytech.com