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
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