IND-Enabling Toxicology
The IND-enabling toxicology package that supports a successful first-in-human submission — designed against ICH M3(R2) and FDA expectations, sized to your molecule, indication, and clinical plan.
The right studies. The right doses. The first time.
Most IND clinical holds trace back to toxicology gaps: missing studies, unjustified doses, or evidence that doesn't match the proposed clinical plan. Our IND-enabling toxicology service builds the safety package that supports your IND first-time — anchored on ICH M3(R2), scaled to your indication and exposure profile, and aligned with current FDA thinking before you commission a single GLP study.
IND Readiness Gap Analysis
Map your existing nonclinical data against ICH M3(R2) and FDA expectations. Identify the studies you actually need — and the ones you don't.
Repeat-Dose Study Design
Two-species repeat-dose strategy scaled to clinical duration, or biologic equivalent under ICH S6(R1) where applicable.
Genotoxicity Battery
ICH S2(R1)-aligned genotoxicity strategy: in vitro / in vivo design, follow-up testing, and impurity considerations.
Safety Pharmacology
ICH S7A core battery — cardiovascular, CNS, respiratory — integrated into your repeat-dose plan to reduce study count.
Dose Justification & FIH
NOAEL-driven first-in-human starting dose, MABEL where required, and the integrated safety narrative that defends both.
Pre-IND Meeting Prep
Briefing document authoring, FDA question preparation, and Q&A rehearsal — so the pre-IND meeting de-risks the submission.
IND-enabling toxicology, sized to your program.
Small-Molecule Programs
Preparing for first IND with NCE risk — full ICH M3(R2) package planning.
Biologic Developers
ICH S6(R1)-aligned strategy, including platform precedent and immunogenicity considerations.
Section 505 & Bridging
Where existing nonclinical data exists, design the targeted bridge studies to support the modified product.
Post-Hold & Resubmission
Programs facing a clinical hold or RTA — rapid root-cause and remediation strategy.
From safety question to defensible IND.
Discovery & Review
Understand the molecule, intended clinical plan, and existing nonclinical data.
Pathway Assessment
Identify the IND pathway and the toxicology evidence it requires.
Tox Strategy
Design the focused GLP toxicology and safety pharmacology plan.
Submission Readiness
Pre-IND meeting prep and IND module 4 authoring.
Standards we work in.
Get an IND-readiness review.
A focused 4–6 week engagement that identifies the studies you actually need and the gaps that need closing.
IND Readiness + Risk Register Sprint
- ICH M3(R2) gap analysis of your current package
- Prioritized study plan tied to your clinical timeline
- Pre-IND meeting briefing outline