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.

Global Experience

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Learn More About Next Breath's Analytical Services

Next Breath is a full service cGMP compliant laboratory specializing in analytical testing of a range of drug delivery systems from early stage to commercialization. We provide comprehensive solutions for the product development process from formulation and CMC support, to finished batch release and post approval stability to regulatory agencies worldwide.

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Qualifications

  • 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.

Instrumentation

  • 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

  • Breath simulator

  • Karl Fischer

  • FTIR

  • Waters HPLC systems

  • GC-MS

  • GC-HS

  • LC-MS