Gateway Analytical Brochures

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We took time to break out our offerings based on market served and service provided. Check here for informative posters, brochures, and more that you can share with your team! Can’t find what you’re looking for? Contact us today.

Company Service Overview
Gateway Analytical is a specialized analytical testing laboratory that businesses around the world trust to provide solutions for their most challenging foreign particulate characterization and materials analysis needs. Learn more about our services by downloading our brief overview brochure.

Foreign Particulate Matter Testing
Having an understanding of process, raw materials, and various steps of production can help to identify potential sources for contaminants. Read through a real customer example of Gateway’s systematic comparison approach to foreign particulate matter testing.

Container Closure Integrity Testing
Testing container closures is important as it ensures a sterile barrier against microorganisms and other potentially dangerous contaminants. Read a real customer example of Gateway’s systematic container closure integrity testing approach.

MDIs and DPIs Service Overview
At Gateway Analytical, we understand that drug development is a complex process that requires astute attention to detail each step of the way. Learn more about our MDI and DPI analytical services by downloading our overview brochure.

Evaluation of Medical Devices
Our multi-analytical approach is essential for providing you with the vital information you require to see your product from the development stages through medical application. Learn more about our services by downloading our brief overview brochure.

Strategic Partnership to Support pMDIs, DPIs, and Nasal Drug Product Development
Learn more about our partnership with Next Breath, enabling our companies to provide drug developers with analytical and product development support from R&D through submission and batch release for Abbreviated New Drug Applications (ANDAs-generics), New Product Applications (NDAs), and 505(b)(2) products.

Gateway Analytical Sample Submission Form
Ready to work with us? Download the sample submission form to get started. 

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.

Empowering Your Journey Toward Enhanced Patient Care

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.