Mass Spectrometry Study

Successfully provided biopharmaceutical programme management and contractor management services to a US-based client for the selection and management of an in-vitro analytical testing company.

  • Conducted research to identify suitable US based service providers offering specific mass spectrometry services to GLP/GMP compliance.  Produced shortlist of recommended companies.
  • Audited shortlist of US analytical test facilities to ensure GLP/GMP compliance.
  • Managed tendering processes including final selection of test facilities.
  • Negotiated a competitive price and provided advice on contracts including Quote and Quality Assurance agreements.
  • Managed analytical testing at service provider to demanding timelines.  Completed 1st study within 5 months from setting up of contracts to final reports.
  • Resourced, led and managed a team of specialist subcontractors for Mass Spectrometry, Quality Assurance, R&D and Regulatory Advice.
  • Produced regular project progress reports as well as financial management reports throughout the project.
  • Due to successful results, the client extended the study significantly, with the project lasting 17 months in total.