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Nitrosamine Method Development

Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing

Gateway Analytical provides advanced R&D-stage LC-MS/MS workflows purpose-built to meet FDA, EMA, and ICH M7 guidelines for genotoxic impurity analysis. Our scientists apply deep regulatory insight and scientific precision to deliver accurate, defensible results that support risk assessment and regulatory filings. With flexible, client-directed validation options, our workflows can seamlessly transition from exploratory to validated use.

Choose Gateway for unmatched analytical expertise, regulatory alignment, and a partner committed to accelerating your 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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