Expert Support Across Development Strategy and Model-Informed Execution
Tailored consulting engagements for regulatory milestones, bioequivalence strategy, and translational decision making.
Engagement Models
Structured for how pharmaceutical programs actually work.
Scientific Advisory
Expert guidance for critical development decisions
Strategic scientific advice for regulatory submissions, bioequivalence planning, model qualification, and development milestone reviews.
- Regulatory strategy and dossier support
- PBPK/PBBM model qualification
- Bioequivalence waiver strategy
- Development risk assessment
Modeling & Simulation
Full-scope mechanistic modeling engagements
Comprehensive modeling projects covering PBPK, PBBM, IVIVC, Virtual BE, and translational pharmacology with full scientific documentation.
- PBPK and PBBM model development
- Virtual bioequivalence studies
- First-in-human exposure prediction
- Population PK and variability analysis
Embedded Support
Ongoing scientific partnership
Sustained engagement with your development team as an embedded scientific resource across the full development lifecycle.
- Dedicated modeling scientist allocation
- Continuous regulatory monitoring
- Software platform access and training
- Cross-functional scientific review
Our Process
From question to confident decision.
01
Discovery
We begin with a focused scientific conversation to understand your program, objectives, and key development questions.
02
Scoping
A clear engagement plan is designed: scientific approach, deliverables, timeline, and success criteria.
03
Execution
Rigorous modeling, simulation, and analysis with full documentation and scientific transparency throughout.
04
Translation
Results are framed for decision making: regulatory submissions, development milestones, and stakeholder communication.
Start with a focused scientific conversation.
Tell us about your program and we will outline the right scientific approach and engagement model.
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