Right‑size your IND plan. We design study sequences, budgets, and timelines that survive reviewer and investor scrutiny and preserve capital.

IND‑Enabling Roadmap

A long, straight, two-lane road with a double yellow line in the middle, running through a wooded area with trees on both sides. The road rises and falls over hills, disappearing into the distance. The scene appears to be taken during sunset or sunrise, with warm light illuminating the trees.

  • Study map & Gantt (nonclinical sequence through IND submission)

  • GLP tox & safety pharmacology outline

  • Bioanalytical & biodistribution plan

  • Dose justification (MABEL/NOAEL)

  • Budget & vendor comparison

  • Readiness checklist for pre‑IND/IND

What you get

Process

  • Scope — modality, species, target organ risks, clinical intent.

  • Design — studies, endpoints, sample sizes, stopping rules.

  • Operationalize — vendor shortlists, timelines, budget ranges.

  • Review — investor‑grade slides, assumptions log, and risk mitigations.

  • Slide roadmap deck + excel sheet with budget projections

  • IND readiness checklist

Deliverables

Do you support protocol development, study monitoring, or report writing for nonclinical studies?
Yes, we support protocol develop, study execution, and study reporting design and advise; execution is via your selected CROs.

FAQs