Nasal
A Partner to Accelerate Your Product Through Regulatory Approval
Next Breath uses the latest instrumentation and methodologies to provide our customers with the highest quality of analytical analysis of nasal drug products. We have the technical expertise and experience when it comes to development of nasal products, including dry powder nasal inhalers. Next Breath works closely with our customers to ensure success at each step from development, CMC to regulatory submission and beyond.
Next Breath's suite of service offerings for nasal inhalation products includes:
Development
- Device Selection
- Method Development
- Method Qualification
- Method Transfer
- Method Validation
- R&D Stability Studies
- IND Enabling Studies
CMC
- ICH Stability
- Clinical Batch Release
- Process Validation
- Temperature Cycling
- Prime Reprime
- Effect of Dosing Orientation
- Effect of Varying Flow Rate
- Device Resistance
- Robustness
Post Approval
- Finished Product Batch Release
- Device Batch Release
- Post Approval Stability
- Stability Reporting
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