XChara Consulting provides engaged scientific and strategic leadership that functions as a true expert partner and seamless extension of your team—from early development strategy through execution, regulatory interactions, and model-informed quantitative decision-making.
Nonclinical DMPK Support
- Discovery and IND-enabling ADME studies
- GLP toxicokinetics (TK)
- Human PK prediction
- Mechanistic PK/PD modeling
- Dose projection and translation
Clinical Pharmacology Strategy
- Clinical pharmacology development plans
- IND-enabling strategy
- End-of-Phase 2 preparation
- NDA/BLA strategy and submissions
- Regulatory interaction support
Model-Informed Drug Development
- Population PK modeling
- PK/PD modeling
- Exposure-response analyses
- Dose optimization simulations
- Scenario evaluation and decision support
Clinical Study Support
- Phase I and II studies
- DDI strategy and studies
- BE/FE/rBA studies
- Mass balance and ADME
- Special population studies
Strategic Team Partnership
- Embedded project team representation
- CRO/vendor oversight
- Cross-functional integration
- Risk identification and mitigation
- Budget and timeline guidance
- Due diligence for in-licensing and out-licensing
Therapeutic & Modality Expertise
- Oncology and inflammation
- Hematology and nephrology
- Small molecules and biologics
- Advanced modalities (e.g., PROTACs, T-cell engagers, targeted radiotherapies)
- Radiopharmaceuticals
