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Isotopic Labelling Capabilities

  • Custom Synthesis of 14C Labelled Compounds to support Pre-Clinical ADME Studies

  • GMP Synthesis of 14C Labelled Compounds for Human AME Studies

  • Expertise in handling 14C Labelled Gases and Volatiles

  • Synthesis of Stable-Labelled Compounds incorporating 2H, 13C, 15N or 18O

  • Ability to perform H/D Exchange on API or Late Stage Intermediates

 

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Isotopic Labelling

Drug Substance

Formulation Development

Drug Product

Bioanalytical Services

Analytical Services

Regulatory & Consultancy

Isotopic Labelling

  • 14C Radionlabelling
  • Stable Isotopic Labelling
  • Capabilities

Drug Substance

  • Process Research & Development
  • GMP & Non-GMP Manufacturing
  • Solid State Services
  • Kilolab / Pilot Plant Manufacture/li>
  • Technology & Capabilities

Formulation Development

  • Non-Clinical Formulation Development (Oral & IV)
  • Early Clinical Formulation Development (Oral & IV)
  • Capabilities

Drug Product

  • Oral & IV Clinical Manufacturing
  • Semi-Automated Fill & Finish
  • QC Testing & QP Release
  • Stability Testing
  • Microbiological Testing
  • Impurity / Degradation Product Identification

Bioanalytical Services

  • Non-Clinical & Clinical Material Bioanalysis
  • Metabolite Identification Studies
  • In Vitro Services
  • Capabilities

Analytical Services

  • Chromatographic Services
  • QC Testing & QP Release
  • Stability Testing
  • Microbiological Testing
  • Liquid / Solid State NMR
  • Thermal Analysis

Regulatory & Consultancy

  • Regulatory Dossiers
  • Site Inspection History
  • Regulatory Complaint Archiving
  • Potential Mutagenic Impurity (GTI) Assessments
  • Consultancy