Method Development Validation Services
From Formulation to Patient
Next Breath provides comprehensive solutions for the product development process from pharmaceutical product development and CMC testing, to finished batch release and post-approval stability for submission to regulatory agencies worldwide. Our pharma solutions offering covers metered-dose inhalers (MDIs), dry powder inhaler (DPIs), nebulizers, and nasal inhalation products. We work with our customers at each step of the method development and validation process to ensure complete customer satisfaction. Our customers rely on Next Breath’s expertise, experience and comprehensive Development Service portfolio to efficiently progress their product towards regulatory approval.
Development Services:
- Device Selection
- Method Development
- Method Qualification
- Method Transfer
- Method Validation
- R&D Stability Studies
- IND Enabling Studies
Methods available with any service:
- Assay
- Impurities and Degradation
- Related Substances
- Preservative Assay
- Particle Size
- Droplet Size by Laser Diffraction
- Aerodynamic Particle Size
- Dose Content
- Uniformity
- Spray Pattern
- Plume Geometry
- Shot Weight
- Surface Tension
- Viscosity
- Moisture Content
- Osmolality
- Microbial limits
- Particulate Matter
- Identification
- Appearance
- Color
- Weight loss
- Net Content
- Nasal Cast Deposition
- Actuation Force
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