News from June 2008 ComplianceControl Consolidates IT Infrastructure Qualification at Alkaloid AD, Skopje - 18/06/08 Following on from the successful ERP implementation of SAP known as AlkaSAP, Alkaloid AD based primarily in Skopje, Macedonia, have continued its program of investment. ComplianceControl have continued to work with Alkaloid AD and further develop the now well established on-going relationship by supporting the continuous development of the IT Infrastructure programme, required as part of the companies growth and approach to the EU and global market place. ComplianceControl support business growth and key objectives of Alkaloid AD, with these finished and actual collaborations. “We shall further intensify our presence on the pharmaceutical market of the EU by developing long-term partnerships in order to ensure our business maintains and builds upon the standards of excellence we have implemented.” Zivko Mukaetov Chief Executive Officer / President of the Management Board "Our IT infrastructure has been recognised as an essential element as we continue to grow as a company. Its control and cost effective management is recognised by the business throughout. Through a carefully managed program of activities, we are now in a much stronger position to move forward.” Nikola Dimovski Asst.Dir. for IT "Our companies continued investment in infrastructure and people is an investment for the future. Collaboration has helped us focus our efforts and ensure that we have matters under control." Darko Georgiev Main System Administrator For further information on Alkaloid AD, visit http://www.alkaloid.com.mk/ The European Challenge – Recent publication in European Pharmaceutical Contractor - 11/06/08 In light of the expansion of the EU, ComplianceControl’s Andrzej Zylicz examines attempts to bring its newest regions into line with regulations, and suggests approaches that might be of vital use in facing up to the compliance challenge. With 2007 being three years since the accession to the EU of the Czech Republic, Cyprus, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, and one year from the accession of Romania and Bulgaria, it is worth taking a closer look at how pharmaceutical life-science companies from these countries are dealing with the very tough challenge of developing and implementing compliant solutions in order to meet EU regulatory requirements. Download file EPC Article 06-2008.pdf

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