Ottobrunn / Munich, Germany, 19 July 2016 – For the marketing and further development of their new software product RImanager, Werum IT Solutions has concluded a partnership agreement with EXTEDO. RImanager is a centralized Regulatory Information Management (RIM) solution on the master data level, which enables pharma and biotech companies to manage their product portfolios according to regulatory requirements. This solution provides the backbone for all regulatory data and processes in the context of approval and administration of medicinal products. RImanager facilitates the management of product master data as well as the planning and tracking of regulatory data, activities, processes, requirements, and approvals – across sites and worldwide.
As part of the partnership, EXTEDO will be in charge of the global distribution, the project execution at the customer’s site, and the definition of functional requirements for new product versions. Werum IT Solutions will be responsible for further developing the RImanager and, on request, assisting EXTEDO in the project execution and maintenance.
“EXTEDO specializes in the development, implementation, and consulting of regulatory affairs solutions for pharma companies and operates worldwide in locations in Germany, Great Britain, and the USA,” says Matthias Köhler, Senior Head of Strategic Program Management, Werum IT Solutions GmbH. “EXTEDO will be a strong and experienced distribution partner on our side whose expertise our customers will benefit from.”
“The combination of Werum’s MES expertise and EXTEDO’s regulatory solution portfolio represents a unique position in the Life Sciences IT market. This combined expertise enables customers to manage their continuously growing regulatory requirements even more efficiently,” says Christian Bohrmann, VP Marketing & Alliances, EXTEDO GmbH.
Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Its out-of-the-box PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies but also by many mid-sized manufacturers. The RImanager supplements Werum’s product portfolio with a regulatory affairs solution. Werum’s manufacturing IT solutions help pharma manufacturers to increase efficiency, improve productivity, and meet regulatory requirements. Founded in 1969, Werum is headquartered in Lüneburg, Germany, and has many locations in Europe, America, and Asia.
Werum is part of Medipak Systems, the Pharma Systems business area of the international technology group Körber. The Business Areas five companies, Dividella, Medical, Rondo, Seidenader Maschinenbau, and Werum IT Solutions, are leading global providers of high-quality solutions for pharmaceutical products' manufacturing and packaging process. As a Medipak Systems company, Werum provides integrated IT solutions for all phases of pharmaceutical and biopharmaceutical production – including process development, commercial production, packaging, and track & trace serialization. Körber unites around 11,500 professionals in industry-leading companies worldwide, achieving annual earnings of 2.3 billion Euros.
www.medipak-systems.com, www.koerber.de/en
EXTEDO is a leading solutions and services provider in Regulatory Information Management (RIM). The company focuses on optimizing its clients’ eRegulatory business processes and is the only vendor that provides solutions covering the entire regulatory landscape. The EXTEDOsuite combines innovation with compliance and quality with usability.