ISI has announced enhanced NeeS (Non-eCTD electronic Submissions) features and functionality in the latest release of its newly launched Regulatory Solutions Suite to make it even easier for pharma organisations to submit licence applications using this format.
The new release of ISI’ Regulatory Solutions Suite (RSS) includes enhanced features and functionality to support NeeS-format licence application.
The product suite addresses the new validation criteria introduced in July, and in recognition that NeeS is now more than merely a ‘transition’ format.
ISIPublisher—a cornerstone of ISI’s regulatory suite of products—can help biopharmaceutical companies manage the multi-country submissions process and publish, manage and validate submissions in any paper or NeeS format.
Although NeeS was originally intended as a temporary, hybrid format, to ease the transition to full eCTD-standard electronic submissions in Europe, the approach has become so popular among national agencies and local operating companies that the format is now expected to remain valid for several years to come. This is contrary to the initial expectation that NeeS-based licence applications would be phased out by the end of 2009, in preparation for full eCTD adoption. In fact of all submissions made to EU agencies in 2008, 43% were electronic (3% eCTD and 40% NeeS).1
NeeS is more flexible and easier to manage than eCTD, making the format attractive to organisations managing submissions on a national basis. Although it does not benefit from lifecycle management , the standard is well recognised and accepted.
“ISI is firmly committed to NeeS for as long as the standard is in use,” notes ISI’s European MD Adam Sherlock. “While some of our competitors appear to be withdrawing their support for the format with the original expectation that such submissions would cease by January 2010, ISI will continue to support it for as long as the standard applies. We recognise that it still has considerable longevity.”
The additional NeeS functionality included in the newest release of the Regulatory Solutions Suite (Service Pack 2), launched earlier this month, will ensure that users automatically adhere to the latest validation criteria set out by the EU NeeS Validation Criteria V1.0, published in August 2009.
Without a special tool for publishing NeeS submissions, managing these licence applications is a very time-consuming, manual process, prone to inaccuracy - due to the complex file names used, for example.
“With our software, NeeS creation and publishing is a ‘push-button’ affair,” comments Kate Wilber, Director of Regulatory Services, ISI Europe. “We offer the ability to create application templates and pre-define file names which is crucial with the latest standard specifications, where the correct file names are a very high priority. File names can be up to 180 characters long, inviting human error, and companies failing to comply with the new requirements could fail the technical validation. With the new release of ISIPublisher, this risk is removed.”
In addition to this functionality, the latest version of the product allows for 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.
1 eCTD Implementation Survey Report - v3.0-20090626; by the Czech presidency of the EU 2009
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 Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
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 recognised charitable organisations.
Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.