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Non clinical statistics

From drug discovery to market supply, Arlenda understands your needs:

  • Product development must be fast
  • Risk must be reduced in both product development and batch manufacturing
  • The robustness of processes and methods must be ensured

Arlenda will address your needs through multiple statistical solutions, including:

  • Statistics for (bio)analytical methods: validation of your methods based on total error concept and tolerance interval approach, validation of your method transfer

  • Quality by Design (QbD): implementation of QbD to ensure robustness of your processes and methods, and to improve your product characterization for lower risks later

  • Design Space: risk computation and predictive assessment of future performance, set up of operating conditions

  • Biomarker validation: design, analysis or report of your biomarker study

  • Product stability: shelf-life assessment, definition of internal release limits, out-of-trend analyses and design optimization

We are the right partner to optimize your processes and methods. Please click here to view some our achievements