Method Development & Validation

Build robust, defensible analytical methods—without guesswork.
We develop, validate, and verify analytical methods that are fit-for-purpose and phase-appropriate. Whether you’re launching a new product, investigating impurities, supporting stability, or responding to a quality event, we work as an extension of your team to deliver clear protocols, reliable results, and documentation designed for regulatory review.

• Method development (HPLC/UPLC, GC, ICP-MS, UV/Vis; MS when needed)
• Phase-appropriate validation aligned with ICH Q2, life cycle product management ICH Q14 and common FDA expectations
• Method verification (for compendial or transferred methods)
• Method optimization and robustness testing
• Documentation package: protocol + report + raw data outputs as required

When designing new methods, it is essential to first ensure the analytes of interest are clearly identifiable before moving into validation studies. The method must not only detect these analytes but also quantify them accurately without interference from other components in the sample matrix. Our Senior Scientists partner with clients to select the most suitable analytical technique—drawing on a complete understanding of the manufacturing process, the matrix composition, and potential interfering substances ensuring our clients have a robust and accurate analytical method to support the life of the product.

Leveraging our extensive expertise, we design scientifically defensible testing protocols that can withstand regulatory review. Our laboratory develops methods using the most appropriate sample preparation and analysis approaches to detect the target analytes. Once an optimal method is established, we provide a detailed protocol and evaluate it in accordance with ICH guidelines to ensure full compliance.

We evaluate performance characteristics appropriate to the method type and stage, including specificity, accuracy, precision (repeatability/intermediate precision), linearity, range, LOD/LOQ, robustness, and solution stability.

• Specificity – the ability to distinguish the analyte from other components in the matrix.
• Accuracy – how closely the results match the true or accepted value.
• Precision – covering both repeatability and intermediate precision to ensure consistency of results.
• Linearity – the method’s capability to produce results proportional to analyte concentration.
• Range – the span between the lowest and highest concentrations that can be measured with acceptable accuracy and precision.
• Limits of detection and quantification – the smallest amount of analyte that can be reliably detected and accurately quantified.
• Robustness – the method’s resilience to small, deliberate variations in test conditions.
• Stability of test solutions – the ability to maintain integrity of prepared samples throughout the testing period.

• Stability-indicating method development
• Impurity / degradant investigations
• Extractables/leachables and unknown peak follow-up
• Raw material / excipient / intermediate testing
• Finished product release support
• Troubleshooting OOS / OOT events and method performance issues