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Bioequivalence Testing Services for ANDA Submission

//Bioequivalence Testing Services for ANDA Submission
Bioequivalence Testing Services for ANDA Submission 2017-11-18T23:37:25+00:00

Focused Testing Services

Our scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of MDI’s, DPI’s, nebulizers, and nasal drug products. We develop a specific program to meet all requirements necessary for in vitro bioequivalence, drug product characterization and stability. At the completion of each project, we will perform statistical analysis and prepare a report ready for regulatory submission.

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Testing Services

Instrumentation

  • Next Generation Impactor
  • Andersen Cascade Impaction
  • Unit Dose Sampling Apparatus
  • Copley Critical Flow Controller
  • SprayView (spray characterization)
  • Automated actuation systems
  • Breath simulator
  • Waters HPLC systems
  • GC-MS
  • GC-HS
  • LC-MS

Methods 

Sprays

  • Single Actuation Content Uniformity

  • Prime Reprime

  • Amount of Drug in Small Particles

  • Droplet Size by Laser Diffraction

  • Spray Pattern

  • Plume Geometry

  • Particle Size

Inhalers

  • Single Actuation Content Uniformity

  • Aerodynamic Particle Size Distribution

  • Prime Reprime

  • Spray Pattern

  • Plume Geometry

Nebulizers

  • Mean Nebulization Time (MNT)

  • Mean Delivered Dose (MDD)

  • Drug Particle and Agglomerate Particle Size Distribution

  • Aerodynamic Particle Size Distribution

  • Droplet Size by Laser Diffraction

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)
  • Accredited to ISO/IEC 17025:2005
  • Subject matter experts in:
    • Analytical chemistry
    • Inhalation physical tests
    • Spray characterization
    • Particle size analysis

Regulatory Experience

We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.

  • US (FDA)
  • EU (European Medicines Agency) & Australia
  • Canada (Health Canada)
  • Americas
  • India
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