Labeling

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  • Preparation of label text according to regulatory requirements
  • Label design to enhance compliance of trial subjects
  • Client’s corporate identity can be integrated into label
  • Labeling with mono-/bi-/multi-lingual label (multi-language booklet label, wrap-around label, with or without documentation part/tear-off label)
  • Robust procedures to avoid mix-ups
  • Re-labeling in case of changes, (e.g., protocol amendments, new ‘use-by date’)
  • Compliance with 2001/20/EC, GMP and national drug laws (e.g., AMG), protocol specifications
  • Tear-off label to document subject compliance & drug accountability
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