Service overview clinical trial supplies

Nuvisan CTS is offering full service in the field of clinical trial supplies. The infrastructure, capabilities and experience enables to support clients in a broad range starting with GMP in-house services in the course of first-in-human trials up to the management of phase II/III trials as also CTS services for post marketing trials.

Due to our past engagements we have a strong track record for IMP management under cool chain supply conditions for biologicals and vaccines. Furthermore, we can combine our CTS solutions with the power of our other service areas to offer tailored solutions for lab kit design and distribution as also the subsequent sample management in the course of multicenter clinical trials.

Neu-Ulm focus on primary & secondary packaging and formulation support plus handling of cool chain supply for biologicals, whereas Sophia Antipolis will be our future competence hub for the development & manufacturing of topical liquid and semi-solid formulations including cosmetic products.

Formulation Development Manufacturing
  • Support to accelerate the clinical start by interim oral formulations like powders for constitution and capsules
  • Full formulation development for topical & oral liquids and semi-solid formulations e.g. emulsions, gels, crèmes, liposomal formulations or microemulsions
  • Over-encapsulation
  • Capsules
  • Tablets
  • Powders
  • Semi-solids
  • Liquids
Primary Packaging Secondary Packaging
  • Blisters
  • Bottles
  • Tubes
  • Sachets
  • Cartons
  • Blister cards (wallets)
  • Child resistant
  • sealing
Labeling Comparator
  • Design of labels for complex study designs incl. randomization list generation & printing of emergency envelopes
  • Printing of label of various types like single, multi-panel labels, flag labels, booklet labels, multi-language labels, barcodes, graphics, various sizes, colors and fonts
  • Sourcing of commercial products
  • Blinding e.g. over-encapsulation
  • Placebo manufacturing
Import QP Release
  • Import from non-EU countries incl. QP declaration
  • Audit of drug substance & drug product manufacturing sites
  • EU re-testing of bulk materials and finished products
  • QP Release
  • Batch Release Testing
  • Import
  • Audit of Non-EU manufacturers
  • QP Declarations for CTA
Storage and Distribution Global Depot Network
  • All storage conditions available (15-25°C, 2-8°C, -20°C, -70°C)
  • Central depot for Europe located in a Brexit protected environment (Germany / Neu-Ulm)
  • Global Depot Network with qualified partner in all relevant regions (Eastern Europe, Asia, America, Australia) for clinical trials
  • Temperature controlled shipments (15-25°C, 2-8°C, -20°C, -70°C)
  • Temperature monitoring
Your Benefits
  • Significant experience
  • High flexibility
  • Tailor-made services
  • All services under one roof
  • Consultancy services
  • Quick-to-Phase-1-Concept
Pharmaceutical testing  
  • Method development
  • Method validation
  • Stability
  • Release testing (under the shared manufacturing license of CTS)

For more details see Pharmaceutical Analytics

 

Contact

Business Development
Please send us an Email!



Exhibitions

EBD
Bio Europe Spring
25.03 - 27.03.2019
Vienna / Austria


Euro Biosimilars
12th European Biosimilars Congress
15.04 - 16.04.2019
Berlin / Germany


Swiss Biotech
Swiss Biotech Day 2018
07.05.2019
Basel / Switzerland