Preclinical Regulatory Strategy
Preclinical evidence isn't an end in itself — it exists to support a regulatory and commercial story. We design preclinical regulatory strategy as a single integrated plan: the studies you'll run, the questions they answer, and the FDA decisions they unlock.
A roadmap, not a binder.
Most preclinical programs accumulate studies. Few have a strategy. The result is a thick package of evidence that doesn't connect to the regulatory decision the FDA actually needs to make. Our preclinical regulatory strategy designs the package as a unified plan — anchored on the regulatory pathway, sequenced against your investor milestones, and built so each study answers a question the next stage requires.
Integrated Preclinical Roadmap
Discovery → DRF → GLP → IND/IDE as one sequenced plan, not a collection of studies. Each milestone unlocks the next decision.
Hypothesis-Driven Studies
Every preclinical study tied to an explicit question — pathway, dosing, safety margin, or translational risk — not just box-checking.
Safety, Efficacy, PK Coordination
Coordinate safety, efficacy, and PK study timelines so results inform each other rather than arrive in isolation.
Stage-Gate Planning
Preclinical milestones aligned to financing stage-gates — so each round of capital is justified by the evidence the prior round generated.
Translational FIH Planning
NOAEL, MABEL, and integrated dose selection that makes the first-in-human starting dose defensible.
Risk Register
A living risk register that tracks every assumption, gap, and mitigation through to IND/IDE submission.
Preclinical strategy at the right inflection point.
Discovery-Stage Programs
Programs leaving the bench and entering the preclinical funnel, where strategy now prevents waste later.
Translational Biotechs
Companies bridging discovery to clinical, where coordinated preclinical evidence becomes a fundraising and FDA asset.
Investors & Boards
Stage-gate review of preclinical strategy as part of capital deployment or portfolio decisions.
First-Time Founders
Founders who need a senior translational expert to architect the preclinical program from day one.
From discovery to IND-ready evidence.
Asset Review
Understand the asset, indication, and target product profile.
Pathway & Milestones
Map FDA pathway and the investor stage-gates that fund it.
Roadmap Design
Sequenced preclinical plan — studies, questions, and decisions.
Execution & Risk Register
Living risk register that travels with the program through to IND.
Standards we work in.
Architect your preclinical roadmap.
A focused engagement that turns a list of planned studies into an integrated, defensible preclinical program.
Preclinical Roadmap + Risk Register Sprint
- Sequenced preclinical roadmap tied to FDA pathway and investor milestones
- Hypothesis-driven study list with explicit decision linkage
- Living risk register for program tracking