„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)
