Leaders in Method Development

The foundation of any successful drug product on their way to market begins with comprehensive method development. Creating scientifically reliable methodologies tailored to your unique research needs is a critical step not only ensuring the integrity and accuracy of your product, but also paving a clear path toward market success.

With the expertise at Gateway Analytical, we empower scientific methodologies and innovations that stands up to regulatory scrutiny, propelling your product forward with precision. We consider factors like sample size, instrumentation, and experimental parameters to ensure the development of a robust method that consistently produces valid and replicable results. For method development that aligns with the highest scientific and regulatory standards, Gateway Analytical is your dedicated partner. 

The Gold Standard in Method Development

At Gateway Analytical, our specialized approach in method development for extractables and leachables focuses on crafting precise testing protocols. We meticulously evaluate materials, solvents, and potential contaminants to identify and quantify harmful compounds. By developing a reliable and accurate testing method, companies can ensure compliance with regulatory requirements and provide safe products for consumers.

Gateway Analytical - Analysis Solutions

Where Reliable Research Begins

Method development testing is a crucial step in creating effective and reliable methods for scientific research. This testing involves a series of experiments and evaluations that help to refine and optimize techniques to ensure accuracy and reproducibility. Various factors, such as sample size, instrumentation, and experimental conditions, are considered during method development testing. The goal is to create a method that yields consistent and valid results that other researchers can replicate.

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.