At Gateway Analytical, our method development and validation services are designed to meet the highest regulatory expectations in the industry. Each assay is strategically crafted to align with FDA, EMA, and ICH guidelines, addressing the critical demands of regulatory compliance and patient safety.

From genotoxic impurity detection to PFAS quantification and nitrosamine risk assessment, our robust LC-MS/MS, GC-MS, and high-resolution MS platforms ensure sensitivity, specificity, and reliability at trace levels. This document outlines our specialized capabilities in support of high-stakes analytical needs—empowering clients to advance products through complex regulatory landscapes with confidence and precision. Trust Gateway to deliver data that stands up to scrutiny—and gets your product to market faster.