Herzogenaurach, 28 April 2008 – The tradition-steeped pharmaceutical manufacturer MCM Klosterfrau based in Cologne will employ the COI-PharmaSuite to support in the drug certification process. The company is furthermore using COI-BusinessFlow 4X, based on COI-PharmaSuite, for its contract management

In an evaluation of software for drug certification, the product of the software specialist from Herzogenaurach prevailed over numerous competitors. The document management system (DMS) of COI has been in use successfully for many years with the pharmaceutical manufacturer Lichtwer, recently acquired by Klosterfrau. "This long-lasting positive experience with Lichtwer and the unique selling proposition of COI-PharmaSuite's integrated archive, document, and workflow management system, were the decisive factors for awarding the contract," according to Mr. Frank Roth, head of central department IT and Dr. Christian Nauert, head of medicine 'Nattermann products' at MCM Klosterfrau. COI-PharmaSuite is based on the integrated archive, document, and workflow management system COI-BusinessFlow 4X, in which all streams of information merge, even across processes and departments. Klosterfrau uses this basis for its contract management. Here, the solution supports in preparing new contracts, managing both new and existing contracts, and in supervising and following up of contracts. Access for authorized employees to the respective contracts differs and is thus controlled by authorization structure.

For drug admittance, MCM Klosterfrau uses COI-PharmaSuite with its modules Regulatory Affairs, eCTD Export, and AMG-EV. The module Regulatory Affairs supports the entire core process of drug admittance in accordance with the official requirements. For instance, as soon as documents relevant for registration are prepared, they are recorded in the system from where they are administered and made available or sent to the registration department for dossiers preparation. Predefined document sets and structure envelopes (e.g., CTD format) simplify dossier preparation while clearance and control mechanisms with specific access authorizations provide higher quality and better security. This is complemented by extensive search functions for dossiers, dossier chapters, drugs, components, scientific papers and catalogs. The structure of the dossiers is based on the predefined NTA- and/or eCTD structure or FDA requirements, respectively. Clearance of the admittance dossiers is also supported.

For the electronical publication of the drug dossier or sections of it, the attached eCTD-Export module exports an electronic copy in eCTD format according to the specifications laid down in the 'ICH eCTD Specification V 3.2, February 2004'.

The AMG EV add-on supports MCM Klosterfrau in compiling the documents for submitting the drug applications electronically in accordance with the 'Bundesinstitut für Arzneimittel und Medizinprodukte' (BfArM), the German Federal Institute for Drugs and Medical Devices.

Information on Klosterfrau
Klosterfrau is a modern pharmaceutical company based in Cologne. In 1826, a nun, Maria Clementine Martin, registered her company with the city of Cologne's commercial register under the name of MCM Klosterfrau. She began producing the real Klosterfrau Melissengeist, Melissa spirit, in large quantities. Today though, the company stands for more than just the famous Melissengeist. The brand Klosterfrau alone includes numerous other OTC products, such as Klosterfrau Mobilind Franzbranntwein, die Broncholind cold remedies, the calmative assortiment Nervenruh as well as Klosterfrau Allergin – the special natural therapy against hay fever. However, other known brands also have their home at Klosterfrau: The vitamin and minerals specialist taxofit, the sore throat remedy neo-angin – the natural therapy against respiratory problems by Soledum, the patented common cold nasal spray nasic, and the cough therapeutic Bronchium. Jarsin and Kwai, for example, are also included. The by far best-know herb candy Ricola has also for many years been marketed in Germany by the Klosterfrau company. The products mentioned are only a digest of the overall portfolio ist; more can be found in the pharmaceutical company's web site at www.klosterfrau.com.