Stability testing

Tailor-made solutions

Tailor-made solutions

All pharmaceutical development activities require thorough stability considerations. Our range of storage capabilities are fully compliant with ICH guidelines. Through our extensive experience in stability studies for all stages in the pharmaceutical product life cycle, Galenica offers support in the design and set up of stability studies, tailor made for your need with full regulatory compliance.

Our stability services include

  • R & D preliminary stability
  • Formal stability studies
  • APIs
  • Finished products
  • Data trending
  • Expiration dating
  • Stability reports

Our stability cabinets are qualified to GMP compliance and operate independently with their own temperature and humidity controls. All storage chambers are continuously monitored by a computerized log system.

Galencia offers the below storage capabilities, fully compliant with ICH guidelines:

  • -20°C/Ambient RH
  • 5°C/Ambient RH
  • 25°C/60%RH
  • 30°C/65%RH
  • 40°C/75%RH

Contact us

Contact us

Galenica provide tailor-made business solutions and offers unique flexibility for our clients, with possibilities to either choose single parts of our service or a complete drug development program.