Pharmaceutical Product/Process Development

Gateway Analytical follows a Quality by Design (QbD) approach to product development. As a proactive and holistic means to drive the drug development process for improved patient safety and product quality, QbD manages risk from initial product concept to commercialization.  As a result, product and process performance characteristics are scientifically designed to meet specific objectives.

Our analytical testing services provide unique characterization tools for understanding product and process development, including:

  • Content and Blend Uniformity
  • Characterization and Identification of Polymorphs in Drug Products
  • In Vitro Particle Characterization
    • Ingredient-Specific Particle Size Distribution
    • Ingredient-specific Particle Shape
    • Particle Interaction
    • Aggregation and Agglomeration Studies
  • Study of Controlled Release Systems
    • In Vitro Ingredient-Specific Particle Size
    • Content Uniformity
    • Layer Thickness
    • Drug Migration
    • Polymorph Analysis

Request a quote for analytical testing services