A Proven Approach to Analytical Method Development
Method development and validation establishes the scientific foundation for generating reliable, reproducible analytical data across all stages of product development and commercialisation.
Broughton develops and validates analytical methods to meet the demands of evolving product formats, regulatory expectations, and commercial timelines.
Whether bringing a new molecule to market, adapting a method for a novel format, or transferring between sites, our approach ensures methods are robust, reproducible, and fit for purpose.
Services are delivered through our GMP-compliant laboratories, and via our UK Home Office Schedule 1 Controlled Drugs Licence, we are also authorised to support testing for controlled substances. Validation protocols are aligned with ICH Q2/Q14, USP, and EMA guidelines.
We are regularly inspected by regulators and operate under UKAS-accredited systems where applicable.
Designing bespoke methods tailored to your product’s matrix, delivery system, and target profile. We combine scientific insight with regulatory foresight to ensure each method delivers accurate, repeatable data.
Method Validation (ICH Q2, Q14, USP, EMA)
Aligned with ICH Q2 and Q14, USP, and EMA guidelines. Validation protocols assess key factors such as precision, accuracy, and robustness to ensure data is reliable, compliant, and ready for regulatory submission.
Method Transfer & Verification
Seamless transfer of methods between sites or partners, with verification and troubleshooting support to reduce delays and ensure reliability.
Troubleshooting & Optimisation
Refinement of legacy or underperforming methods using advanced analytics and scientific insight to enhance performance and reduce variability.
Regulatory Documentation Support
Preparation of validation protocols and final reports for inclusion in CTD submissions and audit-ready records.
Our method development services support innovators across a wide range of product categories and regulatory environments. From pre-clinical R&D to post-market surveillance, we help you build robust methods with confidence.
Our method development and validation services are underpinned by decades of scientific expertise, regulatory insight, and a proven track record across highly regulated and emerging product categories.
Regulatory Confidence: ICH Q2/Q14 aligned protocols and audit-ready documentation
Scientific Depth: Inhalation, cannabis, and novel product experience
Integrated Support: Combine with stability, batch release, or E&L for full lifecycle coverage
Responsive Delivery: Agile teams and flexible project timelines
