Inhalation
A Partner to Accelerate Your Product Through Regulatory Approval
Next Breath scientists work with the latest instrumentation and methodologies to deliver the highest-quality results across our service offerings. Next Breath’s comprehensive service offering is specially tailored for inhalation products, including metered dose inhalers, DPI products (dry powder inhalers) and inhalation solution and suspensions. Our inhalation testing services cover the entire product development process from product development and CMC support, to finished batch release and post approval stability for submission to regulatory agencies worldwide.
Next Breath's suite of service offerings for 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
- Spacer testing
- Robustness
Post Approval
- Finished Product Batch Release
- Device Batch Release
- Post Approval Stability
- Stability Reporting
- Stability Reporting
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