A Partner to Accelerate Your Drug Product

Finding a devoted analytical services partner can often be arduous and in an environment where every minute counts, choosing the right one is critical. Next Breath understands the challenges companies face. We work with customers at each step of the process to 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 bioequivalence of your drug product.

Featured Services

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

Regulatory Experience

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.

Our global experience includes:

  • US (FDA)

  • EU (European Medicines Agency) & Australia

  • Canada (Health Canada)

  • Americas

  • India

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