The eCTD (electronic Common Technical Document) is part of the ICH (International Conference on Harmonization) initiative to provide a common format for the pharmaceutical industry to agency transfer of regulatory information that is acceptable across the ICH regions of the United States, Japan, and the European Union. This initiative is part of the primary ICH goal to facilitate a more economical use of human, animal, and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines.
IABG’s off-the-shelf Submission Management System eCTDmanager® is a high-quality and functional product at a favourable price manufacture and worldwide market out to straight forward assemble and compile compliant electronic dossiers based on the eCTD standard. Especially for small and medium sized companies eCTDmanager means a safe road map to enter the era of eCTD.
The successful acquisition and project fulfillment for a global playing US company has again proven IABG’s technical and business oriented brilliance. Within a 40 day evaluation period managed by Accenture, IABG has shown that it is a leading company within the market of eSubmission Management. As one of the pioneers in the field of electronic submissions for intellectual property in the Life Sciences field we have achieved a level of competence that we apply with care for the success of our customers.
If you want to learn more about us and our products you can meet us personally at the eRegulations 2003 in Lyon. We will actively be presenting us in 2 Tutorials:
- Business-oriented DRA Optimisation: Process Optimization and Improvement of Efficiency in Dossier Management and Post Approval Maintenance (Infotehna)
- Small budget, large EDM integration challenge – Finding the middle ground (Accenture)
