About this Chemistry, Manufacturing and Controls Documentation

Next Breath is a full service cGMP compliant laboratory for analytical testing of inhaled and nasal spray drug products to support your CMC submission. Using the outline in this document for a model dry powder inhaler or nasal dry powder product, Next Breath will customize a program to meet your requirements according to the appropriate stability storage conditions, conduct the relevant experiments according to the Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation, interpret the test results and generate a report suitable for inclusion in your regulatory submission.

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