Laboratory Services

Our laboratory capabilities allow us to rapidly design, develop and evaluate prototype formulation options to speed your progress through development – from preformulation services, to development of preclinical and clinical formulations.

Our laboratory activities include:

• Physicochemical characterisation and preformulation services
• Analytical method development and verification
• Chemical and physical stability studies
• Preclinical efficacy and safety study formulation development (with a special focus on challenging molecules)
• First-in-Human formulation prototyping
• Later phase / commercial formulation prototyping
• Biorelevant dissolution and development of clinically relevant dissolution tests
• Enabling formulations and specialist drug delivery technology selection

SEDA’s laboratories can be used as a standalone service which delivers the ‘nuts and bolts’ of data generation. Alternatively, it can be combined with our drug product consulting service to provide the additional advantage of seamless integration of the experimental plan with top end Strategy, Interpretation and Execution which can maximise value build and speed of development.

Our extensive analytical capabilities and suite of in-house analytical instrumentation allow us to support a range of CMC activities extending from early phase method development stability studies and impurity analysis, through to excipient compatibility studies and understanding product formulation and behaviour. The increasing complexity of pharmaceutical compounds encountered today requires a deep understanding of analytical techniques which we apply to solve the most challenging of problems.

With our breadth of specialist knowledge in chemical analysis and imaging (including HPLC & UPLC, Mass Spectrometry (MS), Differential Scanning Calorimetry (DSC), Infrared and Raman Spectroscopy and UV probe dissolution), our experts offer bespoke method development and consultancy in the characterisation and quantitation of pharmaceutical materials, as well as advising on more complex techniques that can be applied to understand preclinical and clinical in vivo behaviour.