The assessment
What an IND Readiness Assessment Covers
An IND readiness assessment reviews your IND submission before it goes to FDA. It checks the six areas FDA looks at under 21 CFR 312 — nonclinical, CMC, clinical protocol, Investigator Brochure, starting dose and likely FDA questions — and separates what is missing from what is present but weakly justified.
Six areas reviewed in every IND submission
Nonclinical readiness
Pivotal toxicology, safety pharmacology and genotoxicity coverage, and whether the studies support the proposed clinical duration, route and population.
CMC readiness
Drug substance and drug product characterization, analytical methods, stability data for the proposed use period, and manufacturing consistency at Phase 1 scale.
Clinical protocol readiness
Inclusion and exclusion rationale, dose escalation, stopping and pause rules, and safety monitoring that match the nonclinical risk profile.
Investigator Brochure readiness
Whether the IB summarizes nonclinical findings accurately and gives investigators clear reference safety information.
Starting dose and safety margin
NOAEL-to-HED conversion, MABEL considerations for high-risk mechanisms, and whether the safety margin is clearly justified.
Likely FDA questions
Gaps and misalignments across sections that commonly lead to FDA information requests or clinical hold concerns during the 30-day review.
Completeness is not the same as readiness
An IND application can contain every required section and still carry high regulatory risk if the toxicology does not support the starting dose, or the stability data does not cover the clinical supply period. The assessment scores completeness and risk separately, so your team knows where to add content and where to strengthen the argument.
What you receive
- IND readiness score
- Completeness vs. risk view
- Clinical hold risk indicators
- Missing evidence map
- Likely FDA question list
- Prioritized remediation items
Who it is for
Biotech founders, regulatory affairs teams, preclinical and translational teams, clinical development teams, consultants preparing INDs, and investors reviewing IND-stage programs. For deeper detail on each area, see the IND readiness checklist, CMC readiness guide and clinical hold risk guide.
Common questions
- What is required for an IND submission?
- Under 21 CFR 312.23, an IND includes Form FDA 1571, an introductory statement and general investigational plan, an Investigator Brochure, clinical protocols, chemistry, manufacturing and controls (CMC) information, pharmacology and toxicology data, and any previous human experience.
- How is an IND readiness assessment different from a checklist?
- A checklist confirms that sections exist. A readiness assessment also asks whether the evidence in those sections is strong and consistent enough to support the proposed first-in-human study, and flags where FDA is likely to ask questions.
- When should a sponsor run an IND readiness assessment?
- Most teams benefit from a first assessment before the pre-IND meeting and a second one when the IND package is in draft, so remaining gaps can be fixed before the 30-day FDA review clock starts.
Outputs support expert review. They are not legal, medical or regulatory advice and do not guarantee FDA clearance.
Ready to assess your IND?
Request an IND readiness assessment connected to Alenvo.
Check IND Readiness