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Analytical
Method Development

Robust Method Development and Validation that Delivers Effective and Efficient Testing   

Finding a contract research partner that meets your analytical methodology requirements can be challenging. There are many suppliers in the market, but not all understand your business needs and can develop precision methods to ensure the effective characterization of your product.  

 

Broughton - Method Development Testing

Choosing the Right Partner

Method development is a continuous process that progresses in parallel with the evolution of your consumer or pharmaceutical product. The goal and purpose of the method should reflect the phase of your project, and developing a robust method will ensure that routine testing is conducted smoothly and can reduce the required testing.

Ensuring you have the right partner to work with on phase-appropriate method development and validation is critical to your business. A bad relationship or poor test results from an inexperienced laboratory will impact your project timelines, costs, and outcomes.

We have experience developing, validating, and transferring analytical methodologies for various clients across different industry sectors. Our science development team can develop precision methods for low Limit of Qualification (LOQ) levels and is supported by our in-house scientific experts to help interpret your test data and mitigate potential issues, including analyzing deviations.


 

 

Analytical Method Development and Validation at Broughton 


  • Over 15 years  of experience with a clear focus on Quality
  • Confirming feasibility, literature review, candidate method assessment and selection, cleaning assessment, and suitability 
  • Validation to ICH/VICH guidelines, classification of the method, and specifying the validation characteristics 
  • Ability to develop precision methods for low Limit of Quantification (LOQ) levels
  • Experts in chromatographic methodology 
  • Focus on communication and customer service
  • Quality-controlled sample handling processes
  • Scientific experts to help interpret test data

Broughton Stability Storage Analysis Samples

Speak to the scientific development team about your method development, validation, and technology transfer requirements to see how we can support your business.

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Three Stages of Analytical Methodology and Validation

Whatever stage of the product development lifecycle you have reached, we can support your analytical methodology requirements.

Method development and validation consist of three main stages: 

  • Feasibility—to determine if the method will work with your sample; 
  • Development—to optimize the method; 
  • Validation—where the optimized method is validated to the relevant regulatory requirements.
All projects are assigned a dedicated project lead to provide routine status updates and scheduling milestones. 

We offer a fully integrated method development, validation, and analytical testing service so the scientific development team can rely on input and advice from a wide range of laboratory scientists and consultants if your project or business requires additional support.

Our Analytical Methodology Development, Validation, and Transfer Services

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.

Method Feasibility Testing

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.

Method Validation

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.

Technical Transfer

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.

Technical Troubleshooting

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.

Bespoke Method Creation

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. 

Fully Integrated Laboratory Services

Our scientific development scientists collaborate closely with our other laboratory services teams across QC release testing, stability storage, and stability analysis services. This can ensure the smooth transfer of your methods to our Quality Control teams for routine release testing or that your methods are suitable for long-term stability studies, with validated, bespoke stability storage chambers available at several ICH conditions on-site. Our in-house instrumentation team ensures that our systems are maintained to the highest standards to minimize downtime to ensure you meet your commercial and compliance obligations.

2 women scientists wearing gloves and masks

Speak to an Expert

Discuss your project with one of our scientific experts and find out more about how we can help accelerate your product to market to maximize your success.



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Testing Services Resources

Learn more about how we can help bring your product to market through our high-quality analytical testing services.  

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Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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