About this Chemistry, Manufacturing and Controls Documentation

Next Breath is a full service cGMP compliant laboratory for analytical testing of nasal spray drug products to support your CMC submission. Using the outline in this document for a model suspension nasal spray product, Next Breath will customize a program, including method development and validation, to meet your requirements according to the appropriate stability storage conditions, conduct the relevant experiments according to the Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry Manufacturing and Controls Documentation, interpret the test results and generate a report suitable for inclusion in your regulatory submission. Next Breath will use these analytical tests to perform stability studies, drug product characterization studies, clinical batch release testing and finished product release testing.

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