Method Development, Validation & Technology Transfer

We undertake method development work for clients from various industries, working to the principles of the GLP standard as a matter of course. We can develop methods from scratch or according to your specification.

Working to our clients protocols, internal SOP’s or our own state of the art method development guidelines, we can quickly and efficiently develop methods using HPLC, GC, LC-MS and GC-MS instrumentation. We use in-silico techniques to inform column choice as well as for the optimization of separations and have a robust ‘platform’ based approach to method screening. We undertake method development using QbD approaches where required.

Our methods can then be validated to meet FDA and MHRA standards as defined by ICH Q2(R1) guidelines by assessing the following criteria;

  • Specificity and selectivity
  • Analyte precision
  • Intermediate precision
  • Linearity and range
  • Accuracy
  • LOD / LOQ
  • Ruggedness
  • Standard and sample solution stability
  • Robustness (optional)

We are experts in Technology Transfer and are highly experienced in the production and implementation of Method Transfer Protocols. We have a global consulting reputation in troubleshooting method transfer and guarantee method performance as reported in our method development and validation reports.

For each assignment we following our tried and tested ways of working  to ensure the highest quality work is delivered on time and according to specification.

In many cases a client may recognize that there is a need but may not be able to access the right equipment. Hall Analytical can develop a specific method to separate and identify, quantify and even isolate components.

Access to this type of information is especially valuable to Virtual, University Spin-Off and Start-Up companies and we have undertaken a significant amount of work with these types of companies.

Larger businesses are frequently unable to fulfill all of their analytical requirements due to a number of constraints including time, equipment availability or skills shortages.

This offers a very cost and time effective solution. Outsourcing of such work enables companies to keep track of real costs and to see the true financial and scientific benefit.

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