Image Solutions Addresses Need for Broader Regulatory Solution with Fast Approaching FDA Deadline
Industry Poll Reveals Need for Submissions’ Tracking Capability Along with eCTD System
Whippany, NJ & Atlanta (June 17, 2007) According to a recent Image Solutions, Inc., (ISI) industry poll, 45% of Life Sciences executives say their top criteria for choosing a system to manage electronic common technical documents (eCTDs) – an electronic format for submitting new drug applications – is actively tracking submissions. With the FDA’s end-of-year deadline for eCTD fast approaching, the finding reveals that many Life Sciences firms are taking a longer-term approach to the submission process, looking to solutions that satisfy both current regulatory needs and meet the full range of requirements for the future.
“Pioneering Life Sciences organizations are looking at eCTD compliance more broadly than the pending FDA deadline,” said Paul Chung, Senior Vice President, ISI. “While many companies view the changing regulations as a primary driver for process change and system investments, the more revolutionary organizations seek to gain competitive advantage by employing a model that unifies all regulatory information and processes. These organizations require increasingly sophisticated, multi-tiered solutions for managing and communicating information.”
ISI’s approach to submissions is to build a flexible infrastructure capable of adapting to the ever-changing regulatory environment. The company believes Microsoft’s .NET framework provides this flexibility while enhancing user experience with greater customization. ISI’s Regulatory Suite leveraging the .NET platform, manages regulatory information across a broad spectrum and offers a wide range of software applications based on user needs.
Three of the most commonly used products in the suite are eCTDXPress®, for electronic submissions; ISIPublisher®, which enables companies to publish paper submissions in regions that accept non-eCTD electronic submissions (NeES) or paper copy back-ups of the electronic submission; and ISIRegTracker™, for a complete registration and licensing data management and tracking capability.
“We’ve built the Regulatory Suite in a very holistic way with next generation electronic submissions in mind,” added Chung. “Many companies are simply “bolting on” applications to existing systems, thus leaving themselves vulnerable to future regulatory requirements from the FDA and other regulatory bodies. We encourage firms to take advantage of the bigger opportunity to achieve gains through a more comprehensive strategy.”