Consulting — embedded mechanistic expertise for complex modeling problems.
Nanomath partners with pharma, biotech, and academic teams to develop mechanistic, systems, and physiologically-based models — with a particular focus on long-acting drug products and IND-enabling PK/PD work.
Long-acting products
Mechanistic absorption modeling for subcutaneous and intramuscular long-acting injectables, depot formulations, and implants. From release-rate inversion to systemic exposure prediction across multi-month dosing.
PBPK / QSP
Whole-body physiologically-based and quantitative systems pharmacology models — built from first principles, validated against clinical data, and structured for regulatory submission.
Regulatory strategy
Biomarker qualification pathways, IND-enabling modeling reports, FDA Biomarker Qualification Submissions, and EMA QTWP-aligned Context of Use packages.
How we work
- Scoping — we start with the decision the model needs to support, not the data.
- Model architecture — assumption-by-assumption, with full traceability to literature and your data.
- Implementation — built in SAAM II, MATLAB, or custom C++/C# pipelines depending on what the work demands.
- Validation — Bland-Altman, cross-cohort replication, and sensitivity analyses against published benchmarks.
- Documentation — every assumption, every parameter, every choice — written up for audit before the auditor arrives.
Engagement formats
Discrete projects — fixed-scope modeling deliverables with clear handoff.
Embedded support — multi-month engagements where Nanomath sits in the stack with your team.
Regulatory packages — full submission-ready documentation for IND, BQS, or QTWP filings.
Training & transfer — knowledge handoff so your team can run and extend the models internally.
Engage with us
Tell us about the decision you need the model to support and the data you have. We'll get back within one business day with a scoping conversation.