What we do
Stability studies
- Supporting your stability studies for your drug substance & drug product throughout all phases of development (pre-clinical, Phase I-III) & commercialization (Phase IV), according to in-house or custom-made procedures & protocols, compliant with regulatory requirements.
- Developing stability protocols conform ICH guidelines.
- Accelerated and Predictive stability (ASAP) studies including protocols and data interpretation.
- Offering a GMP-compliant & FDA inspected facility, full traceability by means of our LIMS labware system (from intake, throughout storage according to ICH conditions, to final analysis & reporting), dedicated quality assurance department, cross-functionality trained project teams for maximum project flexibility, and in-house engineering department to support our equipment around the clock.