Expectations exceeded: IABG-LSS remains on course for success with 40% sales growth

 The largest contributing factor to this success was the strong-selling product eCTDmanager. The software specifies the structure of electronic submissions and contributes significantly to accelerated dossier compilation and generation for medicinal products. “For companies in the pharmaceutical industry, time-to-market is a crucial success factor”, says Andreas Suchanek, one of the two Executive Directors of IABG-LSS. “With this in mind we improved eCTDmanager in 2005 such that existing eCTD-based submissions could also be imported. This means that manually created dossiers can now also be sufficiently maintained in their life cycle”, explains Suchanek. The fact that customer figures for eCTDmanager tripled within one year speaks for the quality of the product and its high level of acceptance. For this reason, the managers at IABG-LSS are no longer focusing exclusively on the European market. In order to break into the markets of North America and Canada in the long term, much investment is being made into the local development of sales, professional services, software validation, installation and training. The response can already be seen in that IABG-LSS currently has over one hundred organisations as customers. In North America, IABG Life Sciences Solutions has been known under the name EXTEDO since the beginning of February.

EURS is Yours, introduced for the pilot customer European Medicines Agency (EMEA) in 2004, has been successfully implemented in numerous other European regulatory authorities. EURS is Yours consists of a review system that supports the authorities in reviewing eCTD-based approval files. The IABG-LSS makes this product available to the industry free of charge, thus promoting the electronic processing of approvals based on the eCTD standard.

In addition to the ongoing optimisation of existing solutions, the development of new products which enhance synergy within the IABG-LSS portfolio is an additional success factor. In 2005, DOCvalidator was brought onto the market. This software verifies documents with regard to their suitability for long-term archiving and also takes into account the specifications of ISO standards, regulatory specifications from authorities and individual company standards. The advantage is clear: the time-consuming reformatting and new formatting of documents is no longer necessary, thus rendering collaboration with internal and external partners considerably easier and faster.

IABG-LSS also boasts new product developments in the approval of pesticides. An example of this is the new CADDY standard, developed on behalf of European Crop Protection Association (ECPA). IABG-LSS was commissioned with the development of the specification at the beginning of 2005 and successfully completed the CADDY.xml specification after only six months. A conversion programme which converts old CADDY dossiers into new standard dossiers was also implemented by IABG-LSS and now supports the industry and authorities in the efficient migration of old electronic dossiers. CADDY.xml has already been successfully introduced in the German Federal Ministry for Consumer Protection and Food Safety (BVL).

IABG-LSS continues to view the future with optimism. “The path we have chosen has proven best”, says Tore Bergsteiner, another Executive Director of the company. “We will continue to invest in new products and in increasing our regional presence. Here, I am thinking in particular of solutions for ‘Drug Safety’ (PcVmanager), the management of technical information and other labelling documents (PIM/SPL) and CADDY.xml (PlantOS.xml)”, says Bergsteiner. Following the sponsored spin-off in 2004, the young company has gained a successful position on the niche market. Adjusted structures allowed the company to open up new sales channels thereby considerably accelerating growth. On account of the company’s expansion, IABG-LSS has adapted its premises and has relocated. IABG-LSS’s new address is: IABG Life Sciences Solutions GmbH, Einsteinstraße 30, 85521 Ottobrunn, Germany.