Summary of Nasal and Pulmonary Product Development Services
Next Breath is a contract services provider for pharmaceutical, biotech and medical device companies that bring new inhalation and nasal products to market. We provide an array of in vitro services ranging from pre-clinical formulation development to analytical testing, in support of submissions made to regulatory agencies. In addition, Next Breath has broad experience with drug delivery devices including nasal pumps, metered dose inhalers, dry power inhalers, nebulizers and spacers.
Formulation Services: Next Breath has extensive experience in optimizing inhalation and nasal drug formulations including drug suspensions, solutions and biodegradable polymers. We work closely with our clients to optimize the formulation to produce the desired drug characteristics and quickly advance the product into clinical trials.
Testing Services: Next Breath is GLP/GMP compliant full service laboratory for analytical testing throughout the drug development life cycle. We will conduct the necessary experiments, collect and analyze the data and provide the appropriate report for regulatory submissions. Examples include CMC studies, bioequivalence studies and long-term stability studies. In addition, Next Breath provides support for 510(k) submissions for various drug delivery devices. A sample of our lab testing abilities include:
- Particle sizing by inertial impaction (Anderson Cascade Impactor, Marple Miller)
- Plume geometry
- Spray pattern
- Particle sizing by laser diffraction
- Dose content uniformity
- Moisture content
- Metering reproducibility
- Net content/Number of doses
- Pump delivery/Shot weight
- Solubility in propellant
- Priming and tail-off studies
Next Breath works with leading equipment vendors and other laboratories to provide a complete and comprehensive solution for your product. Next Breath management stays current with the latest FDA guidelines. Next Breath also offers consulting services including on-site lab training, seminars and regulatory assistance. To get a more detailed example of our service offerings, please contact us regarding the programs below:
Our Process
Next Breath understands that our clients, like most people, have limited resources. We will help our clients by designing focused studies so that the project goals are achieved in a timely and cost efficient manner. We adhere to strict project management controls and GLP/GMP standards insuring a quality service while delivering the desired results.
We believe that data should speak for itself. We will make inferences based on how your product is performing, not on how we hope to see perform. We trust that our clients will appreciate our candor in assessing their products. Next Breath will identify the strengths and challenges in your product, and assist in its improvement.
Our reports will be timely, and will answer what was asked of us succinctly. We do not agree that "one size fits all." Our reports are designed to meet your needs by keeping your audience (scientists, clinicians, shareholders, sales/marketing personnel) in mind.
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