OBJECTIVES: The Act on the Reform of the Market for Medicinal Products (AMNOG) funds, effective since 01.01.2011, implemented an early benefit assessment of drugs after launch in Germany. This assessment is based on a dossier submitted by the manufacturer for which the Federal Joint Committee (FJC) provides a detailed template. The objective is to investigate the challenges within a pharmaceutical company occurring during the preparation of a dossier. METHODS: First, the template of FJC is analyzed to identify the data and skills needed to fulfill the requirements. These requirements are then linked to specialized departments within the company. Finally, governance principles are developed. RESULTS: Data regarding drug and disease, available treatments and guidelines, clinical study program as well as German epidemiology and cost are needed for the dossier. Consequently, profound skills in medicine, evidence-based medicine and biometrics are necessary to support medical writing of the dossier. The departments Medical, Health Economics & Outcomes Research (HEOR), Market Access, Regulatory, Commercial and Legal are crucial for the development of a successful dossier. To finalize the dossier in time, two teams are defined: One operational team with delegates from Medical, HEOR and Regulatory prepares the dossier according to the FJC-requirements with or without support by an external vendor. Strategic decisions including aspects not confined to the individual product are taken by the cross-functional governance board. Beyond this a close alignment with global and regional Access policies is essential. CONCLUSIONS: The preparation of a benefit dossier requires a new area of cooperation at the local level within pharmaceutical companies involving a cross-functional team. Of particular importance are the HEOR and Regulatory departments where essential information and expertise reside, putting these team in the spotlight.