Novocol Pharma, Inc. offer service "Pharmaceutical Development"
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Service Name
Pharmaceutical Development
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- Dosage Form: Formulation and process development focused on sterile injectable drug products, applying a Quality-by-Design approach aligned with ICH Q8.
- Stability Indication: Container-closure integrity studies and temperature studies confirm critical processing parameters against critical quality attributes for product stability.
- Scale Capability: Scale-up studies validate process performance from development batches toward larger production volumes for sterile injectables.
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