Analytical Testing

Phase-appropriate analytical testing means tailoring methods, validation depth and testing scope to the requirements of each development stage. Early-stage work focuses on foundational characterization and method development, clinical-stage work emphasizes material release and stability, and commercial-stage work supports validation and life cycle management. This approach delivers efficiency while meeting regulatory expectations at every stage.

ICH-compliant stability testing follows International Council for Harmonisation (ICH) guidelines to evaluate how a drug substance or product changes over time under defined storage conditions. Stability data supports shelf-life determination, regulatory submissions and ongoing product quality assurance. We deliver stability studies aligned to ICH requirements across clinical and commercial supply stages.

At the earliest stages, analytical testing builds foundational understanding to support downstream development decisions. This includes drug substance characterization, preformulation and early development studies, and the initial development of analytical methods that will evolve as the program progresses.

During clinical development, our analytical services support material quality, process understanding and regulatory requirements. This includes raw material testing, clinical trial material release testing, stability studies to support clinical supply, and analytical support for manufacturing process optimization.

As products move toward commercial supply, analytical testing supports validation, life cycle management and regulatory compliance. This includes manufacturing process validation support, product lifecycle and ongoing stability studies, and specialized testing such as extractables and leachables, nitrosamine assessment and elemental impurity analysis.

Extractables and leachables studies evaluate substances that may migrate from packaging, manufacturing equipment or delivery devices into the drug product. These studies are increasingly important for regulatory submissions, particularly for parenteral and inhalation products. Our specialized analytical capabilities support extractables and leachables testing as part of broader commercial-stage analytical packages.

Nitrosamine impurities and elemental impurities are subject to evolving regulatory scrutiny, with defined acceptable limits set by major health authorities. Robust assessment is essential for regulatory submissions and ongoing commercial supply. We deliver specialized analytical testing to identify, quantify and control these impurities in line with current regulatory expectations.

Our analytical testing is closely aligned with our formulation development, clinical trial supply and GMP manufacturing capabilities. This integration provides continuity as your program advances – from early formulation work through clinical release and commercial validation – and supports a coordinated approach to product quality across the development life cycle.