Image Solutions Inc., (ISI), a leader in providing software and service solutions to support the drug development lifecycle, today announced that it is unveiling its new end-to-end regulatory submissions solution at the DIA Annual Euro meeting in Vienna, Austria.
Built on the Microsoft .NET Framework, ISI’s complete submission management suite is truly a technology milestone in regulatory submissions as it now gives life sciences organizations of all sizes one flexible, integrated and comprehensive platform from which to manage, develop, review and publish eCTD, electronic and paper submissions. ISI is migrating its suite of submission products to .NET because it delivers complete choice and flexibility to customers who can rapidly accommodate changes in their business needs and differing regional requirements without the need to invest in costly new IT resources. Life Sciences customers can now ‘pick n mix’ according to their submission needs and the ISI suite can scale to accommodate the needs of their business.
ISIPublisher, the latest product to move onto the .NET-based submission suite, allows users to support paper publishing processes, as well as non-eCTD electronic submission assembly. ISIPublisher, combined with eCTDXPress – the product that manages electronic submissions – as well as other industry-leading services and productivity tools, form the underpinning of the company’s submission suite.
“Life Sciences companies face a myriad of technology choices when handling submissions but many are prescriptive or incomplete, satisfying only parts of the process,” says Gilbert Kampfner, managing director of ISI Europe. “We have simplified that choice by developing an end to end, modular, submissions solution that gives companies the choice to select the components that best match their submission needs, be they electronic or paper-based, but with the flexibility to scale and grow and add modules as those needs change. By underpinning our submission suite with .NET we are adding a future-proof flexibility and inbuilt security for our applications which gives great confidence to our customers.”
ISI has earned an enviable reputation for the depth and expertise that it offers in regulatory submissions both in software and services. To date the ISI services team has completed more than 1,000 electronic submissions, including submitting in excess of 350 eCTDs and delivering 65,000 volumes of paper to clients worldwide. More than 150 life sciences companies have come to rely on ISI technologies and services to advise, manage and complete their submissions and this exacting focus on customer service has been rewarded with repeat orders and a very loyal customer base.
“This all encompassing Solutions Platform rapidly connects systems, people and data across the drug development lifecycle to obtain relevant documentation and publish eCTD and CTD compliant submissions,” said Paul Chung, Senior Vice President of ISI’s Software and Services Operations. “Because of the Platform’s flexibility, Life Sciences companies have the option to publish submissions in various formats, including paper, eCTD, NeES (Non-eCTD Electronic Submissions) and proposed standards such as RPS (Regulatory Product Submissions).”
Chung continues, “Regulatory filings are on the increase and we have developed an outstanding reputation and services capability for helping life sciences companies handle the large volumes of documentation needed to comply with evolving regulatory changes. For many customers we offer this as an outsourced service, like an extension to their in-house team, and we use our own technology to manage and complete the submissions. This coupled with our clients who manage their submissions directly means that more submissions are being handled and successfully submitted on ISI technologies than any other comparable solution.”
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc. (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Science organizations as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and has since delivered nearly 1,000 electronic submissions. ISI serves the top 50 Pharmaceutical and Biotech organizations, in addition to the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey, and operations throughout the US, Europe and Asia.