Scientific Update has successfully facilitated the progression of projects from gram scale (discovery chemistry) to kilogram scale in development and tonne scale in commercial manufacture. This includes the preparation of the drug substance chemistry, manufacturing and controls (CMC) sections of regulatory dossiers, as well as dealing with the GMP, QC and QA issues that arise along the way.
Expert advice relating to the overall strategic management of drug development programmes is offered.
A key aspect of our work is to provide a conduit between client and CRO or CMO to ensure the deliverables are realistic and technical challenges appropriately judged to guard against mis-guided (over) expectations and the resultant disappointment. We work with clients world-wide, across different time-zones and cultures, with the common theme to define a realistic cost and time structure then delivery in accord with the time-lines.