BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): Responsible for the authorisation of finished medicinal products as required by the German Medicines Act (Arzneimittelgesetz, AMG)


  • Establishment of project management and project controls
  • Support for the tendering process of the drug information system
  • Support for business and technical design of the drug information system
  • Support for the implementation of the drug information system including project management, requirements management and quality assurance of the contractor’s proposed solution


  • Established standard project management methods and processes including requirements management
  • Built requirements catalogue, quality metrics, business and technical documents for the tender publication and an evaluation schema to support the contractor selection
  • Assessment of the tender responses
  • Conducted the requirements management process and undertook quality assurance on the deliverables of the contractor


  • Definition of the business and technical requirements of the drug information system
  • Selection of a capable contractor
  • High quality business solution to support the needs of the medicinal product market authorisation

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