Pre-Clinical Checklist for IND Submissions

Before your initial submission with the FDA,

check with us

---

        Pre-Clinical Checklist for IND Submission

General Planning

·         Proposed Route of Administration

·         Target Indication

·         Define drug development goals and regulatory strategy

·         Determine target indication(s)

·         Identify the regulatory pathway (e.g., 505(b)(1), 505(b)(2))

·         Confirm if a Pre-IND meeting is needed

·         Develop a list of specific questions for FDA (clinical, CMC, nonclinical)

·         Prepare timeline for IND-enabling activities

Drug Substance & Product (CMC – Chemistry, Manufacturing, and Controls)

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Drug substance information (source, synthesis, characterization)

·         Drug product formulation details

·         Manufacturing process description and controls

·         Stability data and proposed storage conditions

·         Analytical method development and validation

·         Packaging and labeling overview

Nonclinical/Preclinical Studies

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Summary of completed pharmacology/toxicology studies

·         Summary of ongoing or planned IND-enabling toxicology studies

·         Justification for proposed first-in-human (FIH) dose

·         Species selection rationale and relevance to humans

·         GLP compliance documentation (if available)

Clinical Plan

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Draft protocol for Phase 1 study (or Phase 0, if applicable)

·         Clinical trial objectives and design

·         Inclusion/exclusion criteria

·         Safety monitoring plan

·         Risk mitigation strategies

·         Informed consent process summary

Regulatory Documentation

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Request for Pre-IND meeting (if applicable)

·         Proposed questions for the FDA

·         Pre-IND briefing document draft

·         Investigator’s Brochure (if available)

·         IND application planning and structure (Module 1-5 format)

·         Review of relevant guidance documents

Operational Readiness

·         Identify CROs, CMOs, and other partners

·         Develop timelines and resource plans

·         Ensure team roles and responsibilities are defined

·         Intellectual property status reviewed

·         Regulatory consulting company

·         Pre-clinical animal testing facility