Gateway Analytical, a leader in providing analytical services for particulate identification, strives to help customers resolve issues during their drug development and manufacturing processes. Our extensive experience in pharmaceutical testing, materials analysis and forensic investigation allows us to ask the right questions to get the right results. We identify the problem and go a step further to determine the source of any contaminant or product failure in a turnaround time that meets your needs.
Gateway Analytical is FDA registered, cGMP complaint, DEA licensed, and ISO 17025 certified. We ensure that all testing is performed to provide results efficiently and effectively, while maintaining the highest quality standards.
A Multi-tiered Analytical Approach
Using a combination of analytical testing methodologies is critical in the characterization of pharmaceutical contaminants and product defects. By utilizing state-of-the-art instrumentation and specialized testing protocols, we provide a multi-tiered forensic-based testing methodology that provides fast, accurate analysis of the most difficult sample types in order to answer the what, when, why and how of the investigation process.
We offer advanced analytical services for a wide range of pharmaceutical investigation issues including:
- Particle Contamination and Foreign Particulate Matter Identification Services
- Glass Delamination and Defect Analysis Services
- Particulate Source Determination Services
- Product Defect Analysis Services
- Raw Materials Analysis
- Chemically-Specific Particle Sizing with Raman Chemical Imaging
- Pharmaceutical Deviation Services
- Automated Particle Sizing and Chemical Characterization using Raman/LIBS