Analytical Testing for Inhalation Development

Analytical ServicesWhether its discovery, development or manufacturing, Gateway Analytical offers advanced characterization and problem-solving methods for every stage of your drug product’s development.

For Research and Development
We specialize in ingredient-specific particle sizing that can help assess bioequivalence of generic nasal and inhalation drug products. Supporting a critical path opportunity identified by the U.S. Food and Drug Administration, this validated method can help accelerate regulatory approval, enabling faster commercialization.

Chemical Imaging Services Include:

  • Content and Blend Uniformity
  • Characterization and Identification of Polymorphs
  • In Vitro Particle Characterization
    – Ingredient-Specific Particle Size Distribution
    – Ingredient-Specific Particle Shape
    – Particle Interaction
    – Aggregation and Agglomeration Studies
  • Layer Thickness Determination

For Manufacturing and Processes
Our pharmaceutical forensic services take an investigative approach to manufacturing and process issues, applying forensic expertise, analysis and problem solving principles to get to the root of inhalation deviation investigations.

Pharmaceutical Forensic Services Include:

  • Counterfeit Investigation
  • Failure Analysis
  • Foreign Particulate Matter Identification
  • Non-conformance Issues
  • OOS Investigations
  • Particle Contamination Characterization
  • Product Return Analysis
  • Source Determination

Contact Us for Advanced Analytical Services:

Services of Interest:*
Please Select Accident Investigations API Characterization Biological Stains Content and Blend Uniformity Crime Scene Processing Foreign Particulate Matter Fracture Matching FTIR Spectroscopy HPLC Ingredient-specific Particle Sizing Insurance Investigation Lamp Examination Latent Print Visualization Layer and Coating Thickness Measurement Metals and Semiconductor Packaging Particle Characterization Particulate Contamination Analysis Polymer Identification Polymorph Analysis Product Uniformity Questioned Documents Raw Material Testing Reverse Engineering SEM/EDS Trace Contamination Trace Evidence Examination Unknown Material Identification
Please Describe the Services You Are Interested in: