Concept Life Sciences' highly experienced scientists provide a consultative approach and bespoke advice on the most appropriate approach for method development based on the complexity of your compounds.
Our team quickly perform method feasibility studies to provide a timely indication of the level of difficulty before any subsequent bespoke method development is performed.
Methods are then developed and validated to an appropriate level. This ranges from scientific validations that are suitable for early stage investigative studies through to full regulatory validations (FDA, EMA) required to support pivotal clinical trials.
A single point of contact seamlessly directs clients through the various studies within a project (method development to sample analysis) and all elements are performed to the highest quality to ensure data integrity.
Each study is performed in accordance with a plan and is documented clearly for ease of inspection. We provide standardised and tailored formal reports for method validation studies and sample analysis projects. Fast, quality assured, interim data can be provided throughout the life-cycle of clinical studies and PK data analysis can be performed for clinical studies that are not involved in regulatory decision making.