One of the main challenges during research and development is that the information available for an New Chemical Entity (NCE) may be limited. MedPharm’s breadth of knowledge and experience allow us to take molecules in which little is known and develop analytical methods suitable for the stage and scope of the work. We can then take those methods and develop/validate them such that they are suitable all the way through commercial release. Furthermore, we have a wide range of experience with analytical development for generic drugs and can use that experience to develop methods quickly for generic drug products.
Our group provides services designed to meet the needs of our clients during these various stages of drug development, including:
Analytical methods are developed in consultation with the client and are specific to the stage of work. This can range from a simple assay only method for very early R&D work to a fully validated related substances phase appropriate method for clinical trial or commercial batches.
The MedPharm analytical team works under ICH Q2 (R2) guidance for the validation of analytical procedures. This guidance also provides the framework for all analytical work, including R&D development, to ensure that each stage of work flows smoothly into the next without unnecessary repeats of work and phase appropriate methods are developed.
Our group uses HPLC, UHPLC, and GC to analyze a wide range of analytes and provide accurate, high-quality data which is then used to characterize formulations from R&D through to commercial release.
