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Fresenius Kabi

CASE STUDIES
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Fresenius Kabi, a subsidiary of Fresenius SE, is the
European market leader in infusion therapy and
clinical nutrition.

The company also holds a leading market position in both the Asia-Pacific region and Latin America. In the US market Fresenius Kabi is a leading supplier of I.V. generic drugs. Therapy and care of chronically and critically ill patients, both inside and outside hospital, is a key focus of the company. Dedicated to improving patients’ quality of life, the company embodies its philosophy of "Caring for Life".

Challenge

After the implementation of the eCTD was agreed in the ICH region, Fresenius Kabi started looking for a suitable vendor that had developed a tool for eCTD regulatory submission publishing. EXTEDO’s eCTDmanager fulfilled all these requirements, and this tool was purchased by Fresenius Kabi in October 2007 and immediately installed.

Solutions and results

Fresenius Kabi employs a range of EXTEDO products and solutions to streamline its business and to improve efficiency. The eCTDmanager, EXTEDO’s scalable, "all-in-one" electronic submission management system for eCTD, non-eCTD electronic and paper submissions, is used integrated with IBM Score and has enabled Fresenius Kabi to prepare new drug applications and variations.

"eCTDmanager is comparatively easy to use and EXTEDO’s IT support was both fast and straightforward. This was one major benefit for the important roll out of eCTDmanager to our global organisation…We also selected EXTEDO’s DOCvalidator solution. This application reports formatting errors within both MS Word and PDF documents, and we successfully use it to validate the format of Fresenius Kabi templates and regulatory documents, thereby preventing a refuse to file." said Anthony Agidotan, Manager Regulatory Affairs at Fresenius Kabi.

"The EURS is Yours product, EXTEDO’s proprietary solution for eCTD validation and retrieval, helped us streamline many of our processes." concluded Anthony Agidotan.

"The software, easily installed and fully compatible with our existing information system, saved us time and money in meeting the requirements of the EMEA and National Competent Agencies." said Anthony Agidotan.

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