Stability Studies

Kymos Group has two EMA and FDA inspected EU sites providing GMP-certified ICH stability and ongoing stability studies of small or large molecules for global pharma clients, including pharma innovators and generic manufacturers. We analyze a wide range of finished products from tablets, capsules and ampoules to topical products, injectables and powders.

Our two EU sites have walk-in climatic chambers with a combined storage capacity of 100m3 for ICH climatic zones II, IVb plus additional conditions as well as fully equipped laboratories for the development, validation and testing of both small molecules and biologics.

We use comprehensive, fit for purpose method validation designs according to relevant ICH guidelines, US and EU recommendations as well as clients’ requirements.