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Your Nonclinical Development Plan —
Delivered in 5 Business Days

A complete, strategy-first nonclinical roadmap built for your molecule. So you know exactly what to run, when, and why — before you spend a dollar on studies.

Who is this for?

You've made it through lead optimization. You have a molecule worth developing. And now you're staring down a question nobody has an answer for:

Where do I even start with tox?

 

This is for you if:

  • You're approaching IND but don't yet have a nonclinical strategy

  • You're not sure which studies you need, in what order, or why

  • You want a budget before you start talking to CROs

  • You need something concrete to bring to your board, your investors, or your team

Dessi McEntee MS DABT board-certified toxicologist and fractional head of toxicology

What you get:

A comprehensive, study-ready nonclinical development plan built specifically for your molecule, your target, and your clinical indication. Not a template. Not generic guidance. A real plan.

Every plan includes:

Study Roadmap — Every study you need from METID through IND, sequenced in the right order with scientific rationale for each decision

Species Selection — Recommended species with justification grounded in your molecule's pharmacology and regulatory expectations

GLP Study Design — Key parameters, dose selection rationale, and design considerations for your pivotal tox studies

Risk Assessment — The liability flags specific to your modality and target class, ranked by regulatory significance

Regulatory Strategy — How your nonclinical package supports your IND narrative and what FDA will be looking for

Budget Estimate — Line-item cost estimates for each study so you can plan your runway before you commit

Timeline — A visual Gantt-style timeline from CRO selection through IND submission

The Walkthrough — A 60-minute live walkthrough with Dessi where you can ask questions, pressure-test assumptions, and leave with full clarity on your path forward.

Nonclinical toxicology strategy consultant for biotech

SEE AN EXAMPLE BELOW ↓

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Ready?

Here's what do: 

1. Download the proposal

2. Sign the proposal

3. Email the signed propsal and your NDA to dessi@toxistrategy.com 

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