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