Non-sterile Operations

We support drug development with MHRA-certified primary manufacturing, packaging and assembly of medicines for use in clinical trials and investigations.

We have been providing non-Sterile GMP Operations, including assembly, repackaging and blind labelling services since 2013. We have supported over 30 clinical trials and other investigations for investigators in NHS Lothian and the University of Edinburgh.

Our experienced staff provide advice at the study design/project build stage, support IMPD development, ensuring formulation, blinding and product stability issues are appropriately addressed. We also provide direction on outsourcing options, should these be required.     

  • Importation of Investigational Medicinal Products (IMPs) – From EU, New Zealand or Japan.
  • Manufacture of placebo capsule and powder in bottle formulations
  • Over-encapsulate tablets and capsules (for blinding)
  • Manufacture of liquids for internal or gels for external use
  • Design and print of labels for all study phases
  • Support to write Investigational Medicinal Product Dossier (IMPD)
  • Over-label, packaging and assembly of investigational supplies
  • QP Certification of IMP for CTIMPs
  • Storage of investigational products in a temperature-controlled environment (including refrigerated and frozen -20°C)
  • Despatch (via courier) to UK/EU clinical sites

Non-sterile operations were originally licensed in George Square in central Edinburgh but moved to the HTAF labs in the Institute for Regeneration and Repair in January 2026.

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