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Analytical Chemistry

Designing Scientific Studies That Meet Regulators' Expectations on Safety, Quality, and Efficacy 

From new product development to the chemistry, manufacture, and control (CMC) that comes with ongoing manufacture, our consultants will assess your product and design bespoke scientific studies that meet regulatory expectations even when a product has innovative features or a new USP.

Broughton Analytical Chemistry - Advanced Instrumentation

Advanced Statistical Analysis  

Understanding the chemical composition of substances and materials used in your pharmaceutical or consumer product is vital for regulatory compliance. Ensure you have the best scientific insight and expertise to de-risk critical elements of your project. Our analytical chemistry consultants will design suitable studies to support your project and have immediate access to data from our ISO 17025 and GMP compliant testing laboratory facilities to rapidly troubleshoot issues and provide the statistical analysis needed to deepen your understanding.

  • Gap Assessment
  • Product Assessment
  • Study design and identifying opportunities to bridge data to minimize cost and reduce timelines
  • Data analysis
  • Expert protocol and report writing
  • Authoring scientific content for regulatory applications

Increased Efficiency, Accuracy, and Sensitivity

Increase your analytical research's efficiency, accuracy, and sensitivity by working with our highly experienced chemists, who have helped successfully deliver marketing authorizations for several global clients. 

Our analytical chemistry consultants form part of the integrated services at Broughton and collaborate cross-functionally with our regulatory consultants to determine the most appropriate pathway for your product. They also work closely with our analytical services, quality, and external partners, such as contract manufacturing organizations (CMOs), to design and execute product-specific studies to support product development, CMC, and satisfy regulatory requirements.   Analytical data is assessed by our chemistry consultants and toxicologists to evaluate a product's safety profile and output tailored to the client or regulatory requirements.

We specialize in solving R&D project bottlenecks, sensitivity, and data quality issues to help move a project forward.

vials in stability testing lab

Talk with a chemistry consultant to discuss your project to see how we can help your business succeed.

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Our Analytical Chemistry Consultancy Services

Bespoke study design, including method development strategies and close collaboration with our in-house toxicology team to meet regulators’ expectations on quality, safety, and efficacy for innovations and new USPs.

Method Development and Validation Strategy

Product analysis requires a range of specific analytical methods that give highly accurate results with sufficient sensitivity to give insight at low LOQ levels. Our chemistry consultants work with our scientific development team and in-house toxicologists to ensure all the methods are available to;


  • support product development;
  • fully characterize your product;
  • satisfy the specific regulatory requirements;
  • ensure that the analytical method is suitably sensitive for assessments.  


Chemistry, Manufacturing and Controls (CMC)

Maintaining quality and consistency at every stage of the pharmaceutical or consumer product development cycle, including commercial manufacture, is essential for regulatory compliance. Chemistry, Manufacturing, and Controls verify that the product is safe and effective, ensuring the connection between the clinical study batches and the marketed product is maintained.


Our chemistry consultants are experts in this area and can guide you through the various CMC requirements for your product to support a regulatory dossier submission.


  • GAP assessment of current processes and controls against the regulatory requirements
  • Identification of risk and mitigation strategies
  • Establishing the quality target product profile (QTPP)
  • Nitrosamine risk assessments
  • Design and analytical testing requirements of manufacturing process validation
  • Analytical development and validation of methods as per ICH Q2 (R2) Guidance
  • Design and execution of pharmaceutical development studies in line with ICH Q8 (R2)
  • Assessment of container closure systems, including extractable and leachable studies
  • Design, execution, and reporting of stability studies to establish bulk shelf life to support manufacturing and to establish product shelf-life
  • Compilation of pharmaceutical development report with product specifications and justification
  • Batch release testing
  • Bespoke studies to provide an in-depth product understanding, such as
    • Preliminary product assessments to determine product feasibility or product regulatory readiness
    • Competitor product assessment
    • Data bridging strategies
    • Studies to support pharmaceutical and product development
    • Extractables and leachables
    • Packaging and stability/shelf-life assessments

Additionally, we offer chemical consultancy to ensure the validated methods and technologies used in your project's trial and testing phase are transferred to Quality Control (QC) for commercial manufacture.

Toxicology Collaboration

Our chemistry consultants collaborate closely with our in-house toxicologists to create a differentiating partnership. Across all stages of a project, toxicologists are consulted to ensure studies are sufficiently sensitive, and potential risk areas have the right level of focus.


Click here to read more about toxicology services.

Regulatory Support

Expert advice around the requirements for your chosen pathway and support building development and mitigation strategies through innovative testing plans to help guide the next steps in your project.


Click here to read more about regulatory consultancy.

Speak to an expert 

Arrange a meeting with a scientific or regulatory expert to discuss your project and learn how we can help accelerate your product to market.

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Consultancy Services Resources

Learn more about how we can help bring your product to market through our scientific and regulatory consultancy services.


Pharmaceutical Services - Extractables and Leachables

The evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.

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A Guide To Pharmaceutical Marketing Authorisation in the UK

The MHRA is now a stand-alone body issuing national authorisations only. This infographic outlines the routes to a Pharmaceutical Marketing Authorisation in the UK.

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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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