Small Molecule Impurity and Assay Development
Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing
Gateway Analytical offers custom impurity profiling and potency assay development using LC-MS/MS, GC-MS, and high-res QTOF-MS. Our tailored methods support regulatory compliance, product safety, and lot release readiness. With deep expertise in small molecule analytics and a client-focused approach, we provide robust solutions from R&D through commercialization.
Trust Gateway to ensure precision, reliability, and regulatory alignment at every step.
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.