Analytical
Method Development

Supporting your analytical requirements with a broad range of method development capabilities for various formulations and molecules, including small molecules, trace-level organics, solids, gels, liquids, patches, and inhaled products. Our method development scientists have extensive experience delivering analytical solutions from early phase development with “fit for purpose” expectations to ICH Q2 compliant validation requirements. Utilizing various current technologies, including Ultra High-Performance Liquid Chromatography (UHPLC), Liquid Chromatograph Mass Spectrometers (LC-MS), Gas Chromatography Mass Spectrometers, Elemental analysis, and spectroscopy.

Before methods are developed or transferred for a project, performing an initial feasibility study will allow us to determine if the method will work for your sample and meet pre-validation acceptance criteria. It also ensures we have the appropriate instrumentation and capabilities to meet your needs. We evaluate the method for attributes such as precision, linearity, accuracy, and specificity. This helps avoid protocol failures at the validation phase.

The breadth of our scientists’ experience with sample preparation techniques enables us to deliver all your developmental needs from assay and related substances through to trace-level analysis, whether a novel product or optimization of pre-existing methods.

Ensuring methods are stage-specific and fit-for-purpose following ICH guidance and are compliant with the required governing body. Our Method Validation team has a wealth of experience in pharmaceutical and life sciences. All validation activities are performed to the highest standard, ensuring quality and data integrity principles using state-of-the-art instrumentation. We also provide clients with a direct line of communication with the validation team, which provides timely milestone updates.

We provide a full transfer service, from protocol preparation and execution to data processing and report generation and the set-up of your products in LabHQ LIMS. We can support the transfer of your methods and techniques into our facilities for their ongoing analytical provision or to one or more external laboratories. We can also assess that those methods developed and/or validated by us can be comfortably transferred to your required laboratory or manufacturer, ensuring that any limiting factors are included and accounted for.

And if things don’t go as expected, we are here to support you with troubleshooting and method development if required.

Rectifying technical issues with existing methods. Our scientists bring years of experience in understanding technical problems. They are happy to troubleshoot with your in-house team to mitigate potential issues, analyze deviations, and ensure your existing method is fit-for-purpose. We focus on delivering solutions, not just data.

Experienced chemistry consultants, with their understanding of regulations and new product development, advise on bespoke analytical method development and scientific strategies for novel actives, excipients, and new product features. Their expertise can help build a forward-looking testing strategy to ensure costly errors or mistakes are avoided later in the project.