1. manufacturing and quality control

• GMP-compliant manufacture and testing of medicinal products
• Ready-to-use preparation of the test product and distribution
• Patient-related packaging according to random list
• Labelling of the test product
• Provision of manufacturing aids

2. logistics

• Ordering, receipt and storage of test substances, aids and packaging materials
• Receipt and proper storage of goods, stock control
• Documentation of inventory and whereabouts (drug accountability)
• Taking back and proper destruction of medication that is no longer required
• Practical investigations into the stability and (in)compatibility of the medicinal product to be tested
• Storage, return and disposal of unused test products and corresponding documentation

3. pharmaceutical services

• Participation in the preparation of the trial protocol
• Drug information on the medicinal product to be tested
• Pharmacokinetic investigations of the medicinal product to be tested
• Support of the sponsor with the application (BfArM/ethics):
  Preparation of product specifications
• IMPD (Investigation Medicinal Product Dossier)
  Labelling drafts
• Preparation of manufacturing and packaging instructions
  Preparation of the randomisation list
• Randomisation and blinding of test samples or goods