GMP Supply of 14C Radiolabelled APIs & IMPs

Our team provides services for synthesis, purification and analysis  of radiolabelled compounds and subsequent drug product preparation for use in clinical studies following regulatory guidelines. Seven separate GMP manufacturing areas are available to facilitate multiple GMP radiosynthesis projects in parallel. Five successful UK MHRA facility audits have been conducted since 2004.

  • GMP synthesis of 14C radiolabelled Active Pharmaceutical Ingredient (API) - bulk or packaged drug substance
  • GMP-compliant 14C radiolabelled API purification
  • GMP manufacturing of 14C radiolabelled Investigational Medicinal Product (IMP) – drug product
    • Solutions
    • Suspensions
    • Solids for reconstitution ('Drug in Bottle')
    • Hard shell capsules
  • GMP-compliant QC laboratories
  • QA release of GMP 14C radiolabelled API
  • QP release of 14C radiolabelled IMP
  • Support for preparation of regulatory documentation
  • Worldwide shipping of radiolabelled compounds

Manufacture of 14C Radiolabelled Drug Substances and Drug Products for Clinical Studies

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