Gateway Analytical particle analysis services provide customers with a chemically-specific understanding of the active pharmaceutical ingredient (API) and excipient particles within a formulation. This information is then used to determine particle size, shape, aggregation, and dispersion characteristics. We utilize this data to create in-depth analysis reports for our customers, which provide critical insight for nasal, inhalation, semi-solid, transdermal and solid dosage drug products.
|Particle Analysis Services||Contamination Investigation Services|
- FDA Critical Path Opportunity for direct measurement of particle size equivalence in nasal spray suspensions
- Support of patent infringement litigation
- Method development and validation protocol
- Support and guidance for companies going through bioequivalence