Stability studies

Bioglan can provide you with stability studies covering the entire product life cycle. The storage capabilities at Bioglan are fully compliant with ICH guidelines.

We offer:

  • Stability study design and monitoring according to ICH (International Conference on Harmonization) guidelines
  • Accelerated stability studies during product development
  • Stability testing of API (active pharmaceutical ingredient) and finished product
  • Screening stability studies
  • Trend analysis and suggestion for expiry date
  • Stability reports
  • Generation of documentation for Clinical Trial Applications (CTA, EU)/New Drug Applications (NDA, USA)

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