- We design and execute Out of Specification investigations, deviations and laboratory investigations which are critical to assessing the compliance of a company’s quality control strategy.
- We offer analytical support to give a complete physicochemical characterisation of specific OOS samples and products, with special focus to particle properties of drug substance and drug products.
- Investigations include evaluation of method suitability, comparative testing, accuracy measurements and revaluation of critical parameters concerning both sample preparation and measurement.