Pharmaceutical and drug stability
Defines criteria and requirements for pharmaceutical and drug stability studies, necessary to determine shelf life and storage conditions.
Last updated: 2024-07-20
Develop the study protocol considering climate zone IVb conditions applicable to Mexico.
Execute accelerated stability studies (6 months) and long-term studies (per requested shelf life).
Evaluate stability data to determine shelf life and storage conditions.
Prepare the stability report as part of the sanitary registration dossier for COFEPRIS.
Sanitary registration rejection, product recall if post-market non-compliance is detected, fines up to 200,000 UMA.
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