We are able to design, manage and conduct stability testing in order to support regulatory submission.

  • Develop methods to test active substance stability
  • Analytical testing of active substance
  • Observe effects of environmental factors: Light, temperature and humidity
  • Statistical analysis of results
  • Evaluate storage solutions for active substance


Project validation is assessed using Quality Risk Assessment strategies in order to determine critical stages in the process and analysis.  Equipment used within a critical stage is qualified before validations are undertaken.  The scope and level of process validation will depend upon the number of batches of materials to be manufactured.




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