Cebiphar has an important climatic chambers storage capacity. We perform stability studies in the course of development projects or post-marketing studies. With regards to medicines, stability programs are carried out in strict compliance with ICH-VICH guidelines.

Our objective: to assist you in your pre and post marketing studies

  • Stability studies for :
    • Requests for clinical studies authorisation (IND, IMPD)
    • Registration files (NDA, Security report)
    • Post-marketing studies (on-going stability)
  • Studies for APIs, bulk products and finished products
  • All ICH-VICH conditions, long term, intermediary and accelerated conditions
  • Pre-stability studies for formulation screening
  • Forced degradation studies for:
    • Demonstration of the stability indicating features of the methods
    • Identification of the potential degradation products
  • Freezing/defrosting cycles
  • Photostability studies
  • Support studies for transport conditions

Our services: stability studies and storage

  • Development and validation of stability indicating methods
  • Design of stability studies protocols (bracketing, matrixing) – protocols are reviewed by our Regulatory Affairs unit
  • Storage in climatic chambers and samples management
  • Samples analysis and management of OOS/OOT – involvement of our Pharmaceutical Expert

Our storage capacity

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Security of samples

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