Triple Quadrupole LC-MS/MS
Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing
In-house method development and validation for trace-level leachables, genotoxic impurities, and targeted contaminants. Backed by industry-leading experts and ISO-accredited labs, Gateway Analytical delivers fully customized solutions. Trust our team’s deep regulatory and technical expertise—contact our analytical specialists at info@gatewayanalytical.com or (724) 443-1900.
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.
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Early-Phase Development
Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.
Container Closure
Integrity Testing
Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.
Particulate
Analysis
Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.
Medical Device
Analysis
Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.
Extractables
& Leachables
Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.