IND Gap Assessment

Find filing risks before FDA does.

A prioritized gap assessment across CMC, nonclinical, and clinical — each gap tied to a source, labeled by risk, and paired with a recommended action.

Request an IND gap assessment
What you get

A finding you can act on, not a score to interpret.

A prioritized gap list

Gaps ranked across CMC, nonclinical, and clinical — each tied to a source, each with a recommended action.

Predicted reviewer questions

Questions a reviewer may raise, clearly labeled as predictions — not a claim about FDA’s internal systems.

Recommended actions

A concrete next step for each gap, so your team spends time on judgment instead of searching.

Illustrative example

What a finding looks like.

Three findings from an illustrative gap assessment of a hypothetical sterile injectable IND. Each states the gap, its basis, what was and was not located, and what to do next.

CriticalCMC

Container closure integrity has not been adequately demonstrated over the proposed shelf life.

Regulatory basis
21 CFR 211.166 · USP <1207> · FDA CCIT guidance, 2008
CMC evidence
CCIT method qualification data not located in supplied documents. Shelf-life CCIT data not located in supplied documents.
Recommended action
Provide qualified CCIT methodology and supporting data covering the proposed container-closure configuration and shelf life.
CriticalNonclinical

The proposed human starting dose is not traceable to a no-observed-adverse-effect level from the pivotal repeat-dose toxicology study.

Regulatory basis
21 CFR 312.42(b)(1)(i) · 21 CFR 312.23 · FDA maximum safe starting dose guidance
Nonclinical evidence
NOAEL determination for the most sensitive species not located in supplied documents. Human equivalent dose scaling calculation not identified in documents reviewed.
Recommended action
Provide the NOAEL for each species with supporting toxicokinetic exposure data, and document the human equivalent dose derivation and safety factor applied.
MajorClinical

The dose-escalation protocol does not define stopping rules or dose-limiting toxicity criteria.

Regulatory basis
21 CFR 312.42(b)(1)(i) · 21 CFR 312.42(b)(1)(iv) · FDA grounds for clinical hold
Clinical evidence
Dose-limiting toxicity definition not located in supplied documents. Cohort-level escalation and de-escalation rules not identified in documents reviewed.
Recommended action
Add an explicit definition of dose-limiting toxicity and the criteria for escalating, holding, de-escalating, and stopping dosing.

Illustrative example. Critical, Major, and Minor are Amia’s own risk classification, not FDA deficiency classifications. “Not located in supplied documents” means the item was not found in what was provided, not that the evidence does not exist.

Who it's for

  • Pre-IND sponsors preparing to file
  • Regulatory leads at emerging biotech
  • Teams without a full in-house regulatory function

What to send

  • The IND sections you have drafted
  • The nonclinical summary
  • The clinical protocol

Timeline & format

  • Confirmed on the scoping call
  • Delivered as a written report with sources
  • A walkthrough call so your team can act on it

Request an IND gap assessment.

Tell us what you are working on. We will tell you what a scoped engagement would cover and how it would be priced.

Request an IND gap assessment Email us