Method development & validation
As companies focus on achieving ever shorter timescales for transitioning from drug discovery to market application, it is vital that a tailored and pragmatic approach is adopted for both method development and validation.
Successfully developed and validated analytical methods can reduce overall turnaround times and underpin a robust product. By starting with the endpoint in mind, methods can be developed to have flexibility built in during the early stages. This can enable seamless translation from API to drug product, potentially reducing costs throughout the product lifecycle.
Our cross-laboratory, multi-disciplinary approach, combined with our exemplary customer focus and communication, make us an ideal partner for method development and validation activities.
Drawing on over 30 years of experience working with a diverse client base and a multitude of different dosage forms, we can support you in developing robust, fit-for-purpose methods appropriate for analysis of potency, purity, physical characteristics and stability.
Our experienced team offers a wealth of knowledge and advice on areas ranging from sample preparation and extraction techniques to regulatory requirements and specialised methodology.
Following successful method development, we can perform phase appropriate method validation according to the ICH Q2 (R1) recommendation for the analytical procedure. We can also validate methods developed by other laboratories.
Additionally, we can perform a gap analysis of previously validated methods to ensure they meet the current guidelines and maximise the likelihood of a successful regulatory filing. All our work is conducted according to the method parameters set out by the ICH guidelines.
We use a wide range of techniques to ensure method development and validation is completed to the highest standard, including:
