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
Reliable ICH-compliant stability storage and GDP-certified storage for when capacity is tight, timelines matter, and product integrity needs protecting. For more than a decade, Q1 Scientific has supported pharmaceutical, biotech, and medical device companies by storing their samples and products in our specialist stability storage and GDP‑certified storage facilities across Belgium, Ireland, and the US.
Partner with us for secure, stress free, and compliant storage delivered with precision and reliability.
