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Custom Method Development and Validation Across Multiple Platforms

Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing

Need a tailored analytical solution? We develop and validate your custom methods across our entire suite of advanced instrumentation, including triple quadrupole LC-MS/MS, QTOF-MS, and GC-MS systems. All validations rigorously adhere to ICH Q2(R2) guidelines, ensuring reliable and compliant results.

Gateway offers flexible validation of client-specific methods across all in-house instrumentation, including triple quadrupole LC-MS/MS, QTOF-MS, and GC-MS systems. All validations are performed in accordance with ICH Q2(R2) guidelines. Reach out to our analytical experts to learn more!

 

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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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