ezGMP and Associates Inc, a New York-based international company has signed a distribution agreement with Felten GmbH - Germany, for the commercialization of its ezGXP 4.5 software within key European countries, including Germany and Switzerland.
EzGXP 4.5 is a unique 21 CFR Part 11 compliant solution for FDA-regulated companies that use Microsoft Excel in the generation of manufacturing and quality control data subject to FDA review and oversight.
"The agreement signed on August 3, 2004 provides Felten with an important opportunity to distribute a significantly improved compliance tool for the regulated industry. After a lengthy evaluation of the features of the product by our technical and marketing staff, we concluded the product has been well-designed and its performance will interest our clients," stated Werner Felten, CEO of the company.
"The agreement with Felten provides ezGMP and Associates Inc an important entry point into the European market with the best partner any company would want to have for promotion and distribution of this type of product", added Joe Rodriguez, ezGMP's chief technology officer and founding partner, when asked about the selection of Felten.
The programme is currently being installed in Central and South America, and Puerto Rico.
ezGMP and Associates Inc develops and commercializes software solutions for the FDA-regulated industry. In addition, it provides consulting services on current Good Manufacturing Practice to companies seeking approval of new products or improvements to quality systems in order to comply with FDA and international current good manufacturing practice regulations.