Harsewinkel, June 16, 2010 - arvato services healthcare is offering a new complete solution for the market launch of pharmaceutical products in Europe. The solution is aimed at companies from Europe, the U.S. and Asia who want to enter this lucrative but highly fragmented market without having to put their own infrastructure in place. As well as comprehensive consulting, the full service provider takes over all supply chain activities and ensures that the market supply is managed efficiently and in accordance with customer demand. The services offered range from clinical studies and import/export management to finishing, distribution, order processing and pharmacovigilance to financial management and reporting.

According to the Federal Association for the Pharmaceutical Industry, the European pharmaceutical market grew by 10.5 percent to around €192 billion in 2009. In Germany alone, the second largest pharmaceutical market in the European Union, revenues of around €33.4 billion were generated. The biopharmaceutical drug segment performed particularly well, achieving a 9.7 percent growth compared to the previous year. Despite these impressive growth figures, there are many obstacles preventing the pharmaceutical companies from operating in several or even all European countries at the same time. The reason for this is that there is still no standardized internal market in the pharmaceutical sector. Instead, each country has its own health system with correspondingly complex regulations. This means that new drugs not only have to be approved by the respective national health authorities, but the reimbursement rates and conditions for these drugs have to be negotiated with each individual national insurance institution. These problems are compounded by language barriers and a lack of distribution models, all of which make it harder for companies to enter the market.

This is where the full service offer from arvato services healthcare comes in. "The key benefit for our customers is that, in all European countries, we put in place highly efficient process structures for the whole supply chain, explains Dr. Thorsten Winkelmann, President of arvato services healthcare. As a full service outsourcing partner, arvato can perform all services that are needed from the time that the goods are requested by the customer to the delivery to the end customer. These not only include export and import management (customs formalities, VAT processing), but also warehousing, order management, finishing, distribution, order processing and financial management in accordance with the Sarbanes- Oxley and SAS 70 regulations. The company places great emphasis on data and processing transparency which is ensured by means of regular quality, financial and sales reports.

arvato services healthcare also uses an extensive network of partners to help its customers to plan and implement clinical studies from phase II onwards in accordance with the law and to manufacture smaller product quantities in different dispensing forms in compliance with the GMP regulations. The full service provider manages all of the processes, packages and labels the products for specific countries and also establishes the specified infrastructure for pharmacovigilance in a number of languages. Whilst observing the respective national regulations, arvato is also able to distribute a number of individual preparations to individual persons under a "Named Patient Sales" program, even before official approval has been given. "We think that a lot of companies will want to use this full solution", says Winkelmann. "Many pharmaceutical companies have developed their products until they are almost ready to be launched and are intensively involved in opening up the European market. We are able to draw on our comprehensive know-how and global arvato network to provide these companies with optimum support when entering the market."