Expectations fulfilled: IABG-LSS on track for success

 The managers of IABG-LSS see their products, which simplify and greatly accelerate the approval procedure for drugs and agrochemicals, as providing the company with a new impetus. Manufacturers can use the software to create approval dossiers in a structured manner. The integrated workflow and document management system allows optimum handling of all sub-processes across the entire product life cycle. Other options include a facility that allows different employees to work on the same document in parallel, a systematic procedure of version and variant administration as well as the automated generation of XML-based dossiers in the format required for submission to the relevant regulatory authorities.

In the context of progressing international harmonisation, interdisciplinary expertise relating to the creation of electronic approval dossiers and to the electronic processing of the approval procedure is becoming increasingly critical. This explains the company’s success in opening up new markets. The vast majority of its new customers are based in neighbouring European companies and in the US. Practical experience of submissions has already been acquired in Austria, where the authorities especially favour and encourage electronic processing. However, the list of customers also includes the European subsidiaries of large Asian groups. The installation of the eCTDmanagers with the BayX30-company, GPC Biotech, represented the first step by IABG-LSS into the American biotechnology market.

IABG-LSS presented <link http: www.extedo.com external-link-new-window externen link in neuem>eCTDmanager to a large audience at the Toolkit Showcase session of the 18th Annual DIA Electronic Document Management (EDM) Conference in Philadelphia, PA. The session organizer prepared a set of documents for a sample eCTD submission and participants were asked to demonstrate how the documents were imported into their respective tools. IABG-LSS demonstrated the ease of document import, submission creation and the powerful graphical user interface that allows simple add/replace/delete functions integrated with submission lifecycle management. Users do not need to know anything about xml code to prepare a fully compliant eCTD submission.

Attendees who stopped by our exhibit booth after the presentation, consistently rated eCTDmanager as one of the top 3 applications in terms of ease of use and functionality. "This did not simply happen by chance", according to Tore Bergsteiner, one of the two executive directors of IABG Life Sciences Solutions. "Our work takes into account the <link http: www.iabg.de infokom software_einfuehrung v-modell_en.php external-link-new-window externen link in neuem>V model for software development and, in particular, the "Ergonomic Engineering" guidelines. This enables us to ensure that our products are actually tailored to meet the needs of users instead of being simply IT-centered". These statements illustrate the pedigree of a large proportion of the specialists in this field, as this topic has been a focal point of IABG activities for many years.

Andreas Suchanek, the other executive director, attributes the company’s success to its consistent development of the market and the ongoing innovation of its products. The sales partnerships with global system integrators also proved to be particularly beneficial to the company. Our partners provide their own platforms and business solutions into which our products can be incorporated without additional work and expense. This synergy is of benefit not only to IABG-LSS and its partners, such as Documentum, IBM, CSC and Neeb&Partner, but above all, to the customer.

The fact that the trust placed in the products of IABG-LSS is well-founded is also reflected in the high degree of acceptance by approval authorities. After only a few months, the newly founded company’s circle of customers already included the most important European authority (EMEA, European Medicines Agency). Since January 2005, IABG-LSS has been developing the specification for a new open standard, CADDY-xml, on behalf of the European Crop Protection Association (ECPA). CADDY-xml will be used to support the harmonised electronic submission of crop protection substances both to the industry and to the relevant authorities.