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.