Stability Studies

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At PSR we have a dedicated group of qualified personnel to conduct stability studies of drug products and substances in compliance with ICH guidelines. We have reach-in stability chambers including refrigerated and freeze thaw conditions as well as photo stability and an option to scale up depending on a clients future requirements. We offer Stability Study Services to support all phases of Drug Development:

  • Pre clinical Stability study Management
  • Phase I – IV stability study management
  • Accelerated / stressed stability to support early specifications
  • Late Development stability programs to support final specifications and establishing product shelf life
  • Registration Stability for NDA / MAA fillings
  • Marketed product stability to ensure commercial quality control