NUVISAN has a service provider mindset and is highly experienced and flexible thanks to two GMP facilities located in Europe. The packaging of blister cards, wallets and patient kits is adapted to the specific clinical trial and its requirements. In case of temperature sensitive products, NUVISAN performs the secondary packaging in one of our walk-in refrigerators or walk-in freezers.
The CTS department offers (re-)labelling of IMPs which are stored at <-60 °C (labelling done at -20°C on dry ice), at -20 °C, at 2-8 °C and at 15-25 °C. All activities are done in a GMP environment, under controlled conditions using warehouse electronic inventory system.
For the labelling of the IMPs, NUVISAN has a portfolio of diverse label types (e.g., single labels, flag labels, wrap-around labels, and booklet labels), which is selected based on the individual needs of a study. Barcodes, QRD codes, graphics, fonts, and colors can be varied on the labels. NUVISAN offers randomization services by using an own qualified and validated software or integrating a randomization list, which is provided by CLIENT or the clinical CRO. The printing of emergency envelopes can also be performed by NUVISAN´s CTS unit.
Once the kits are ready for shipment, in-house Qualified Person Team ensures the certification or final product release.
Until the distribution of the IMPs (on local or global scale), NUVISAN stores the medication according to the respective requirements (15-25°C, 2-8°C, -20°C and <-60 °C) under GMP conditions. We support global clinical trials by using qualified courier and depot services.
At the end of a clinical trial, NUVISAN’s CTS unit performs the return drug accountability and final destruction including the provision of a respective disposal certificate if requested.