Services
Six focused services that turn FDA toxicology and regulatory complexity into clear, fundable decisions — for founders, biotechs, medical device companies, and the investors who back them.
Pick the focused engagement that fits your moment.
FDA Toxicology Consulting
Translate safety risk into pathway, study, and submission decisions. The flagship engagement — for founders preparing first FDA contact or programs facing a clinical hold.
Learn more →IND-Enabling Toxicology
The ICH M3(R2)-aligned safety package that supports a successful IND first-time. Repeat-dose, genotox, safety pharm, and FIH dose justification.
Learn more →Medical Device Biocompatibility
ISO 10993-aligned biocompatibility planning and chemical characterization for 510(k), De Novo, PMA, and EU MDR — scoped to your contact category.
Learn more →GLP Toxicology Strategy
GLP study design and sponsor-side CRO oversight — right species, right doses, right endpoints, defensible the first time.
Learn more →FDA Pathway Consulting
Find the fastest viable FDA pathway — IND, IDE, 510(k), De Novo, BLA, Section 505, or combination — and the evidence story to support it.
Learn more →Preclinical Regulatory Strategy
An integrated preclinical roadmap from discovery to IND/IDE — evidence designed to convert to approval, not accumulate in a binder.
Learn more →Book a strategy session.
A short call to surface your most pressing FDA question — and identify which engagement (or combination) fits your program.
Regulatory Pathway + Risk Register Sprint
- FDA pathway mapped with key questions and decision points
- Prioritized study strategy tied to your milestones
- Investor-ready risk register and submission narrative