Regulatory Experience Around the World
Next Breath understands the challenges companies face when it comes to getting a drug product to market, and we have a proven track record of working with regulatory agencies to ensure a higher product approval rate.
We work closely with our customers to help ensure not only customer satisfaction but also product stability and quality for meeting regulatory demands in addition to critical support for ANDA Submission and developing the necessary study programs to demonstrate the bioavailability and bioequivalence of your drug product.
cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA.
Registered with FDA (last inspection January 2016 – no 483s).
DEA license for controlled drug substances (schedule II-V).
Subject matter experts in analytical chemistry, inhalation physical tests, spray characterization and particle size analysis.
Next Generation Impactor
Andersen Cascade Impaction
Unit Dose Sampling Apparatus
Copley Critical Flow Controller
SprayView (spray characterization)
Automated actuation systems
Polarized light microscope
Spray force tester
Waters HPLC systems