Consultancy would be conducted in 3 phases

Phase 1 (listening)

  • Discuss and understand customer requirements
  • Define the type of analysis required e.g. regulatory, fast turnaround
  • Define the main requirements and analytical challenges e.g. screening assay, low level quantification, small/large molecule, large no of samples, limited sample volume, stability concerns, budget

Phase 2 (Development and transfer)

  • Develop appropriate method(s) in the BioApp lab to meet customer requirements
  • Advising on fit-for-purpose approaches for efficiency
  • Include all aspects of analysis sample prep, chromatographic system (inlet) and detector
  • Validate to Bioanalytical method validation testing guidelines (EMA 2012 and FDA 2018)

Phase 3 (Sample analysis)

  • BioApp to provide continued support throughout the lifespan of the project including regulated activities and advising on addressing regulatory audits
  • BioApp to troubleshoot method and support on regulatory issues

If you are interested in any of the above services or if you would like to discuss what we can offer, please contact BioApp.