The Drug Development Engine “Accelerating Molecules to Medicines”
This graph demonstrates acceleration of IND enabling toxicity studies and CMC requirements for Phase I clinical studies, which in turn, shortens the drug development timeline.
TCG GreenChem brings together in a dynamic project team environment, the critical aspects and attributes toward developing a ”First Time Right” synthesis of the API with the appropriate polymorphic form and properties that allows for the acceleration of the IND enabling toxicity studies and subsequent the Phase I clinical study. This is accomplished by utilization of state of the art analytical instrumentation and high throughput experimentation for the identification and rapid development of the “Ideal” route of synthesis of the drug candidate. This is accomplished via the project team consisting of our experienced process research, solid state and pre-formulation scientists. This acceleration is highlighted in the graph above by the increased slope of the “black” Process Research curve. Process Development, Formulation Development and Clinical development can all be accelerated by the timely supply of the cGMP API.
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