The primary focus of our work at SEDA is to add value to our Clients. We achieve this through the pragmatic application of scientific excellence in Pharmaceutical Technology and Clinical Pharmacology. Our ambition is to provide our Clients with the experience and level of expertise that may be found in the development functions of major pharmaceutical companies but with the speed and flexibility required in the fast moving biotech sector.
Seda Pharmaceutical Development Services provide Pharmaceutical Development and Clinical Pharmacology services and consultancy to the Pharma and Biotechnology Industry. We enable the rapid and efficient development of optimal medicinal products by providing coherent and synergistic support.
Our areas of expertise include oral drug delivery, DMPK and dose selection, pharmacokinetic modelling, complex medicines, paediatric product development, regulatory CMC and clinical pharmacology.
Seda has a team of experienced Project Leaders that can provide a full consultancy service for our customers.
Our services span CMC, Clinical Pharmacology and DMPK. This ranges from input at the pre-clinical / discovery phase, through first-in-human and early clinical trials and onwards to product approval.
Our laboratory capabilities allow us to rapidly design, develop and evaluate prototype formulation options to speed your progress through development – from preclinical presentations, through First in Human studies and on through the clinical phases.
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.
Computer modelling and simulation is a method that can be used to predict and/or confirm drug and formulation behaviour in vivo and facilitates the understanding of the exposure/response relationship. Modelling and simulation integrates data to mitigate the risks of drug properties impacting drug absorption and uncovers the relationship between dose, exposure and biological effect.
Modelling and simulation is used throughout development to guide and support longer term development strategy and clinical investment decisions. It puts emerging clinical data into context with preclinical and clinical data already available. Modelling and simulation can therefore build confidence in the development of your chosen compound/formulation leading to reduced clinical testing and costs.>
To find out how we could add value to your project, contact us on email@example.com
For general information, please visit www.sedapds.com