New FDA Stability Storage Guidelines
The FDA have issued a New Stability Guidance document earlier this month for ANDAs which now requires stability data on three batches to be generated as opposed to one batch..
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Q1 Scientific – a Cambrex company
With over a decade of expertise, Q1 Scientific safeguards critical breakthroughs at state-of-the-art stability storage facilities across Belgium, Ireland, and the US.
Facing space constraints, chamber failures, or missed testing time points? We provide cGMP compliant stability storage, adhering to ICH and custom R&D conditions. Partner with us for 100% on-time sample pulls and compliant storage, so you can focus on research.
