We can review your ongoing stability studies, or plan new ICH compliant studies from conception through to setting of shelf life.
If required, we can outsource sample storage and/or analytical testing.
The initial requirement is to develop and validate appropriate methods and implement specifications for the duration of the study. These will be incorporated into the stability study protocol. The protocol will cover product details, storage condition, pull points, sample quantities and overage and if the work is carried out externally, contractual information such as reporting timelines.
We can prepare a comprehensive stability report and advise on setting the shelf life for your drug substance or product.