- One solution addresses all submission types and formats
from paper through to NeES and eCTD -
Eschborn, Germany – October 6th, 2008 – Image Solutions Inc. (ISI), a leading provider of software and services to streamline the regulatory approvals process, today announced the launch of a new and extended set of modules across its Regulatory Solutions Suite that directly addresses the submission challenges faced by European pharmaceutical companies. Enhancements and additions to ISIPublisher and eCTDXPress , as well as a new module in ISI Submission Manager (ISM), ease the transition from paper, to non-eCTD Electronic Submissions (NeES), through to full electronic common technical document (eCTD) submissions, for European pharmaceutical companies.
The challenges facing European regulatory operations teams are evolving and therefore becoming increasingly complex. Many health authorities have announced their intent to migrate to fully electronic submissions, while others are still entrenched in a paper submission process. As all authorities must be capable of receiving eCTD-only submissions by the end of 2009, the next 15 months are critical for European pharmaceutical companies managing this transition.
Most authorities will accept non-eCTD electronic submissions (NEES), but may still consider paper the legal basis for submission. This is a contributing factor in the delay in adoption of eCTD currently as each country needs to pass legislation through its respective parliamentary body to accept an electronic format as a legal document. In this transition phase, pharmaceutical companies could be faced with creating different submission formats (eCTD, NEES, paper and sometimes in parallel) to meet the requirements of the EU member states. Additionally, many of these companies rely on affiliates in their local countries, thereby adding further complexity to the electronic submission compilation process.
The latest release of the ISI Regulatory Solutions Suite provides enhanced integration between the tools and additional functionality in ISIPublisher to specifically meet the NeES and paper requirements that are still business-critical to European customers. New functionality highlights include:
• A bolstered XML-parsing engine enabling the automatic creation of tables of contents (TOCs) with the appropriate entries to conform to the NeES guidance. This also offers increased flexibility when creating paper output.
• Document-level ‘Scaling Control’ for flexibility in output creation, specifically for paper output.
• The ability to process Virtual Bookmarks, a new feature that will assist publishing teams with creating compliant NeES output.
• An enhanced eCTD import capability that simplifies the transition to a full eCTD, particularly important to organisations using document management systems
“Europe presents a unique set of regulatory submissions challenges in Europe and ISI is at the forefront in its understanding and management of submissions from paper, through NeES to eCTD,” explains Adam Sherlock, Managing Director of ISI Europe. “We are a worldwide leader in eCTD submissions, having just delivered our 1000th eCTD through our services organisation; however we completely understand the need to support NeES and legacy formats for Europe during this transition period.”
Adam added, “We also recognise that the need for paper will not go away at the end of 2009, as the eCTD will not be required in all countries. Furthermore, we know that many ‘rest of world’ countries are not ready for electronic submissions at all. Therefore, the value and functionality that we are adding into the Regulatory Solutions Suite can now also be leveraged for emerging markets such as Brazil, Russia, India, China and beyond. We are proud to be able to address this European challenge head on and help new and existing clients navigate through the submissions complexity by fully supporting them through each stage of the journey.”
The ISI Regulatory Solutions Suite can be purchased as an end-to-end suite, or as standalone modular applications. ISI Submission Manager (ISM) allows users to track documents through ISIPublisher or eCTDXPress, and comes with ISIPublisher 3.1 and eCTDXPress 3.2. Another key component of the ISI Regulatory Solutions Suite, ISIRegTracker, offers a comprehensive registration tracking and licensing management solution, completing the information management requirements of any Regulatory Operations/Affairs department.
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies 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 since has delivered thousands of submissions. The company has a 49 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress, and 4 of the top 10 pharma now have ISIPublisher.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organisations. For more information, visit the company website at www.imagesolutions.com.
Carina Birt, Sarum
PR for ISI Europe
+44 1722 41115-
This press release was distributed by ResponseSource Press Release Wire on behalf of Sarum PR in the following categories: Business & Finance, Medical & Pharmaceutical, Computing & Telecoms, for more information visit https://pressreleasewire.responsesource.com/about.