Gateway Analytical is a full service cGMP compliant, FDA registered and inspected laboratory, that offers a unique forensic-based method to contamination analysis. Stemming from 18 years of experience in pharmaceutical testing, forensic investigation and materials analysis, our method allows us to not only quickly identify contaminants, but also answer the who, what, when, how and why of the investigation process.
Our methods, coupled with state-of-the-art analytical instrumentation allows us to solve commonly encountered problems such as when and where foreign particulate matter entered a manufacturing process, pinpointing the root cause of product failures or investigating the source of product discolorations. Understanding that time is of the essence, we work quickly and diligently with our customers to trace contaminants back to the source and lead them to a solution, often in days not weeks.
- Foreign Particulate Matter Identification
- Nonconformance Issues
- Out of Specification Investigations
- Particle Contamination Characterization
- Contamination Source Determination
- Product Return Analysis
- Counterfeit Drug Investigation
- Failure and root cause analysis
- 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