At Next Breath, we value the importance of educating our clients on the latest technology and regulatory guidances. We make every effort that customer expectations match their deliverables. We review your requirements, answer your questions and develop a plan to meet your requirement with careful considerations to your budget before work begins. Below is a listing of some of the resources you can browse. If you have any questions about Next Breath’s services or would like to request a quote, please contact us.
This document provides a sample outline of a model dry powder inhaler program designed to meet expected storage, experiment and report expectations for regulatory submission.
This document provides a study design for a model air-jet nebulizer, customized to meet expected requirements, selecting a predicate device, analyses and report expectations for regulatory submission.
This white paper highlights key considerations and presents strategies to reduce risk and ultimately accelerate the process for gaining approval of an ophthalmic product.
This white paper discusses the key considerations and a stepwise approach that we believe are critical in managing the complexities and unknowns around the development of generic pMDIs.
This article discusses in vitro nasal spray characterization and when to perform the necessary tests in the development cycle of a nasal spray product.
In this study, two nasal spray pumps were used to evaluate the effectiveness of manual and automated actuation and the effects of variations in actuation parameters.