FDA Toxicology Consulting
Strategic FDA toxicology consulting for founders, biotechs, and medical device companies — translating safety risk into clear regulatory pathway, study, and submission decisions before capital is committed to the wrong evidence plan.
FDA-aligned toxicology, not generic safety testing.
Most FDA delays don't come from bad science — they come from misaligned science: toxicology evidence built without a clear regulatory destination. Kandih's FDA toxicology consulting starts with the pathway question (IND, 510(k), De Novo, BLA, Section 505) and works backward to define the safety package that supports it. The result is fewer studies, the right studies, and a submission the FDA can clear the first time.
Pathway-Aligned Tox Planning
Toxicology evidence designed against the specific FDA pathway your product will pursue — IND, IDE, 510(k), De Novo, BLA, or combination.
Gap Analysis & Risk Register
Identify where your current evidence falls short of FDA expectations, and build a defensible risk register investors and reviewers can follow.
Study Prioritization
Sequence the studies that change pathway, dosing, or approval decisions — and defer the ones that don't yet matter.
Pre-Submission Strategy
Pre-IND, Pre-Sub (Q-Sub), and Type B/C meeting preparation — briefing documents, questions, and FDA-ready Q&A rehearsal.
CRO & GLP Lab Oversight
Sponsor-side oversight of contracted toxicology studies — protocol review, vendor selection, monitoring, and report integration.
Submission Narrative
The toxicology section of your IND, IDE, or 510(k) — written to anticipate FDA questions, not just answer them.
FDA toxicology consulting at the moments that matter.
First-Time Founders
Preparing for your first FDA engagement and need a senior FDA tox consultant to set the pathway before spending on studies.
Investors & Boards
Evaluating safety risk before deploying capital, or commissioning third-party regulatory diligence on a portfolio company.
Clinical Hold & RTA Programs
Facing a clinical hold or refuse-to-accept letter and need a rapid, focused re-strategy of the toxicology package.
Cross-Modality Programs
Drug, device, biologic, or combination products where safety risk assumptions break down across modalities.
From safety question to submission-ready answer.
Discovery & Review
Understand the product, intended claims, target market, and current safety evidence.
Pathway Assessment
Identify the fastest viable FDA pathway and the evidence it requires.
Tox Strategy
Design a focused toxicology and preclinical plan aligned with FDA expectations.
Submission Readiness
Prepare regulatory documentation and execution plan for FDA engagement.
The standards that govern your submission.
Book an FDA strategy session.
A focused engagement that converts ambiguity into a pathway-aligned toxicology plan — in 4–6 weeks.
Regulatory Pathway + Risk Register Sprint
- FDA pathway mapped with key questions and decision points
- Prioritized toxicology strategy tied to IND / 510(k) / financing milestones
- Investor-ready risk register and submission narrative