Selection of NCE's for development
Evaluation of "developability" of NCE's
Basic pharmaceutics, preformulation and form selection
Early development strategy for rapid progression to human testing and proof-of-concept
Formulation strategy (oral and injectable dosage forms, large and small molecules, including selection of compositions for safety testing and rapid first-in-human dosing)
Finished product process development
Stability study design
Technology transfer
CMC regulatory strategy
Implementation of Quality-by-Design
Timeline analysis

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