packaging.pdf
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Clinical Packaging Services 

In addition to our manufacturing and development capabilities, we provide a wide range of packaging services to suit your clinical trial or commercial requirements, all to cGMP standards. Whether using our packaging services in conjunction with our manufacturing or in isolation, SCM delivers finished product worldwide, direct to sites. Our team of packaging experts can provide you with the following packaging solutions -

Core services  

• Labelling and packaging for Phase I, II and III clinical trials to FDA requirements
  for the following:
  • Individual patient kits
  • Blinded or un-blinded patient kits
  • Randomised patient kits in various formats including crossover, comparator, parallel etc.
• Labelling and packaging for commercial purposes
• Generation of randomisation lists (designed and generated at SCM pharma or designed by client)
• Bulk packaging and labelling of products and components
• Pack-downs (capsule shells, ampoules, vials, bottle tops, stoppers etc)
• Blister packaging services to suit small volume and complex operations for clinical trial and non-clinical trial use
• Device assembly design and combination pack assembly 
• Bespoke design of clinical and non-clinical labels including:
  • Foreign language labels
  • Barcodes
  • Branded labels
  • Design of clinical patient kits or packaging for commercial packs
  • Design of clinical randomisation lists
• Distribution
  • Cold chain distribution
  • Overseas distribution direct to study sites - worldwide
• Additional services
  • Technical packaging consultancy which
  includes reviewing clinical protocol for accuracy
  • Regulatory advice
  • Technical support service
  • Audit of suppliers
  • Equipment and process validation
  • QP services