Service Categories
Drug Development Strategy
Program design and end-to-end development roadmaps
Gap analysis before major early clinical development milestones
Support for communications with regulatory and investor audiences
Drug Development Strategy
First-in-human (FIH) dose selection and escalation design
Recommended Phase 2 dose (RP2D) and RDE strategy
Translational PK/PD bridging from preclinical to human
QSP modeling evaluation and analysis
Food-effect, DDI, and formulation bridging plans
IND/IB/Protocol authoring and regulatory support
Scientific & Investment Diligence
Scientific review for investors and M&A teams
Data-driven evaluation of development risk
Benchmarking against peer mechanisms and reference drugs