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 presentation examines SEM-EDS and Raman Spectroscopy as a means to accelerate generic drug applications. Presented on October 2017 at the 6th Medicon Valley Inhalation Symposium (MVIC) by Julie D. Suman, PhD.
This poster focuses on the utilization of the SPE© automated Raman spectroscopy system and its ability to measures the count, size and shape of particles, and chemical characterization.
This presentation examines global regulatory requirements along with regulatory approaches for bioequivalence and an overview of FDA drug specific guidance.
This presentation examines regulatory approaches for bioequivalence and a comparison of compendial testing and pharmaceutical equivalence for Brazil.
This document provides a sample outline of a model suspension nasal spray product program designed to meet expected storage, experiment and report expectations for regulatory submission.
This presentation gives perspective to understanding the rationale for nasal and pulmonary drug delivery and provides guidance for differentiating between device attributes for inhalation and nasal platforms.