Clinical Supplies

„Designed for Compliance”

  • Conversion of the study design to optimal packaging design
  • Packaging: Blistering, bottling in multipledose containers, blinding,
    visitpackages, patientkits, center-boxes, shipping-boxes
  • Filling/aliquot of liquid, semi-liquid and solid formulations
  • Blistering of Alu-PVC-, -PVC/PVDC-, -PVC/Aclar®-foil, and others
  • Layout creation, labelling and printing of stickers and patient
    information in accordance with GCP-guidelines
  • Manufacturing of clinical supplies in accordance with §13 AMWHV
  • Testing / QC of finished clinical supplies in accorance with §14 AMWHV
  • Release by the Qualified Person in accordance with §16 AMWHV

Procurement of Comperator Products and Clinical Supplies

  • Procurement of medicinal products base on our Wholesaler License
  • Import of clincial supplies from non-EU countries, in particular asia and north america, based on our Import License, §72 AMG (Medicinal Product Act)

Dispatching of Clinical Supplies

  • Dispatching of clincial supplies all over the world together with our qualified logistic companies

Selection of the Suitable Batch of the Comparator Product used for Bioquivalence Studies

  • Analytical Service
    – Recording of dissolution profiles besed the Guideline on the Investigation of Bioequivalence
    – Determination of excipients and API to show quantitative similarity to the comparator product
    – Check of applicability of the biowaiver considering the Biopharmaceutical Classification System (BCS)
  • Galenical Development
    – Manufacturing of lab batches considering „Biowaiver-Results“
    – Manufacturing of lab batches confirming the similarity of investigational medicinal product and comparator product
    – Manufacturing of lab batches for stability testing (on-going during the clinical study)