GLP Toxicology Strategy
GLP toxicology study design and sponsor-side CRO oversight that produces defensible data — the first time. Right species, right doses, right endpoints, scoped to the regulatory decision the study has to support.
Pivotal studies designed to be defensible — not just run.
GLP studies are expensive to commission and far more expensive to redo. A weak GLP toxicology strategy — wrong species, indefensible dose levels, missing endpoints — turns a pivotal study into a liability. We design GLP studies that support specific regulatory decisions, oversee CRO execution under 21 CFR Part 58, and integrate the resulting data into a submission narrative reviewers can follow.
Protocol Design
GLP-compliant study protocols built backward from the regulatory decision the data will support — IND, IDE, 510(k), or BLA.
Species & Dose Justification
Pharmacologically relevant species selection, dose-range finding strategy, and NOAEL-driven dose level setting.
CRO & Lab Selection
Match study scope to lab capability — capacity, regulatory track record, and historical control data — before the contract is signed.
Sponsor-Side Monitoring
In-life monitoring, audit-trail review, and quality assurance liaison — so deviations are caught early, not in the final report.
Report Review & Defense
Final report critical review, anticipated FDA questions, and the toxicology narrative that integrates results into your submission.
Network Coordination
Where multiple labs, sites, or study types are running in parallel, coordination across a vetted GLP/CRO network — so timelines don't slip.
GLP strategy at the moments that matter.
First-Time GLP Sponsors
Companies commissioning their first pivotal GLP studies and need senior judgment on design and CRO selection.
Multi-CRO Programs
Programs running studies at multiple labs and need a single accountable point of GLP oversight.
Post-Hold Resubmissions
Programs where prior GLP studies were challenged and need re-strategy, not re-run.
Investor & Diligence Reviews
Third-party review of an asset's GLP toxicology package as part of due diligence.
From regulatory question to defensible data.
Decision Framing
What regulatory question must this GLP study answer?
Design & Justify
Protocol, species, doses, and endpoints — designed and defended.
Execute & Monitor
Lab selection, in-life monitoring, and QA liaison.
Interpret & Integrate
Report review and integration into submission narrative.
Standards we work in.
Book a study strategy call.
A focused engagement to design — or critically review — the GLP studies your submission depends on.
GLP Study Strategy + Oversight Sprint
- Protocol design or critical review against your regulatory pathway
- CRO / GLP lab vetting and selection support
- Monitoring plan tied to your submission timeline