SERVICES
Method Development
Melbourn Scientific provides method development to ICH guidelines.
To ensure successful method development there is a requirement for highly skilled analytical judgement. Ideally the method development exercise should start with a 'clean sheet of paper to allow information to be gathered that is uncluttered by past events. However if there is relevant history to the development project then this will be taken into account.
The 'purpose' of the method needs to be determined with some clarity and thoroughness as this will ultimately determine the long-term success of the new method. Other aspects of information and those that relate to the actual analyte in question and the 'other' materials that may be present in the analytical mix. The strategy for the method development process will result from this initial information gathering exercise.
The result of this review is an objective outcome that ensures the developed method will be as 'fit for purpose' as possible, given that the requirements of the method have been sufficiently well defined. However, methods are adapted for similar situations and made to fit other challenges that come along during the development process. With our wealth of experience in this area we can discuss with our client the development strategy to allow the method to be developed for as wide a range of application as possible together with as simple, rugged method as we can obtain.