Our experienced team offer services to develop and validate robust methods for analytical testing.
We can support with a wide range of matrices from API to formulations. The types of products we work with range from solid dose, liquid and injectable formulations through to medical devices, from small molecules to peptides, covering the human and animal healthcare industries.
We can develop methods according to your needs, from assay and related substances methods for a new product or API to optimising pre-existing methods to utilise current technologies such as UHPLC. Our service can encompass all aspects of the method from sample preparation to results generation. We can also assist in rectifying technical issues with existing methods.
Method validation is stage specific and fit for purpose following ICH guidelines. We offer method validation services for methods developed in-house and at other laboratories.
We offer a service for non-routine analysis, this could be anything from performing a stability study on a new product to obtain data for a stability study to urgent testing on a released product to prevent a recall. We have also supported clients with other non-routine work such as cleaning validation and licence updates.
Case Study
Download and read our case study on how we helped our client reduce production downtime through method development and validation of a 'clean in place' procedure which adequately detects traces of flush solvent.
Checklist
Download your free checklist to ensure you covered all areas for a compliant and effective test method transfer.
Case Study
Download our case study to read how we helped our client maintain regulatory compliance and extend product shelf-life through our method development, validation and stability management service.