Image Solutions, Inc. | Press Releases

Image Solutions, Inc. Completes 38th eCTD Submission

Whippany, NJ (October 19, 2004) – Image Solutions, Inc., (ISI) a leading global provider of eCTD (Electronic Common Technical Document) solutions for the Life Sciences industries, has completed it’s 38th eCTD submission on behalf of it’s clients. The eCTD is a globally accepted electronic submission structure emerging as the standard for the United States, the European Union, and Japan for new drug submissions. This number represents a significant percentage of the total eCTD’s submitted to the US Federal Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) since January, 2003. The accomplishment demonstrates ISI’s continuing leadership position in this rapidly evolving area of regulatory document standards.

It also brings to bear ISI’s ability to quickly and creatively adapt to almost any client situation, provide regulatory operations and eSubmission expertise, and proficiently compile and manage an eCTD submission. What may be most impressive however, is the fact that ISI’s clients have never received a refusal to file (RTF) from any regulatory agency for submissions outsourced with ISI. To date, ISI has successfully completed 13 eCTD submissions to the European Union (EU) involving four different products, and 25 eCTD submissions in the US for three different products.

The work required to complete these 38 submissions was performed entirely by ISI OneSource, the eSubmission service and support division for ISI. ISI OneSource provides its worldwide clients with superior eSubmission services, regulatory operations expertise, and training for the management of mission critical information. Using ISI’s proprietary software tools like ISIToolBox, eCTDXPress, CRFTrack, DocComposer, and ISIPublisher, ISI provides the foremost Life Science organizations in the world with personalized services to quickly compile eSubmissions in line with strict regulatory guidelines. ISI OneSource can assist clients with a variety of other eSubmission-related requirements including volume document archiving and conversion, medical writing, submission assembly, ePublishing, web hosting as well as staff augmentation.

About Image Solutions, Inc.

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 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 organizations 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 recognized charitable organisations. For more information, visit the company website at www.imagesolutions.com.

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.