Method Development, Validation & Technology Transfer

Smiling young chemist using the machineWe undertake method development work for clients from every industry and work 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.

Working with Hall Analytical
Our approach to working with clients is simple and well defined – understand your needs and exceed your expectations.

We achieve this using a process that has allowed us to deliver business critical data to our clients, both large and small, for the past 20 years;

  • Work with you to fully understand your requirements and clearly define the analytical scope and deliverables
  • Develop a study plan and have you approve the workflow
  • Include Milestone exit points throughout the workflow of more complex projects to lower your overall risk
  • Discuss project progress at regular intervals and consult on major project decision points
  • Generate the highest quality data, on time and deliver your information in a world class report
  • Ensure you fully understand the results produced and assist you to contextualise the data and use it in an appropriate way

COMMITTED TO EXCELLENCE:

We are committed to providing assurance to our customers by operating and maintaining a quality management system based on the requirements of ISO17025, UKAS, and GLP
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