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Comprehensive GC-MS and LC-MS Screening

Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing

Gateway Analytical is advancing comprehensive GC-MS and LC-MS screening workflows for volatile and non-volatile extractables. Designed for in-depth characterization, these methods enable identification and structural elucidation of unknowns—critical for E&L studies and material safety evaluations. Our team combines advanced instrumentation with regulatory knowledge to deliver clear, actionable data.

Rely on Gateway’s analytical excellence to uncover risk, ensure compliance, and support product development with confidence.

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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.

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Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

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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.

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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.

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Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.

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