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 ANDA submission. Using the study design in this document for a model suspension nasal spray product, Next Breath will customize a program to meet your requirements, conduct the relevant experiments according to the Draft Guidance for Industry: Bioavailability and Bioequivalence of Nasal Aerosols and Nasal Sprays for Local Action, interpret the test results and generate a report suitable for inclusion in your regulatory submission.

Download CMC Documentation