We provide you with supportive stability data for your drug substance and drug product throughout all phases of development (pre-clinical, phase I-III) and commercialization (phase IV).
We help you design the right study for your product and put in place the proper protocols.
We support a wide range of studies, including forced degradation (temperature, pH, oxidants, light stress, etc.), long-term storage for shelf-life estimations (in line with ICH conditions), in-process stability testing (e.g. holding steps), manufacturability testing (e.g. mimic impact of manufacturing steps on your molecule), in-use stability testing and clinical compatibility.
We apply both in-house and custom-made procedures and can ensure full traceability by means of our in-house labware system (from intake, to final analysis & reporting).