Pre-IND checklist

 

1. Preliminary Strategy and Planning

• Define the drug product and intended indication

• Identify target patient population and unmet medical need

• Conduct competitive landscape and IP analysis

• Draft a regulatory strategy roadmap (IND → clinical trials → NDA/BLA)

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2. CMC (Chemistry, Manufacturing, and Controls)

• Define drug substance and drug product specifications

• Develop a manufacturing process and controls

• Identify GMP-compliant vendors (for later stages)

• Provide preliminary stability data

• Draft early CMC development plan

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3. Nonclinical/Preclinical Development

• Conduct or plan for:

  • Pharmacology studies (primary and secondary)

  • Toxicology studies (GLP-compliant)

  • Dose-range finding studies

• Assess the need for IND-enabling studies, such as:

  • Genotoxicity

  • Safety pharmacology

• Develop a nonclinical summary and timeline for GLP studies

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4. Clinical Development Plan

• Draft first-in-human (FIH) study protocol (usually Phase 1)

• Define:

  • Study objectives, endpoints

  • Patient population (inclusion/exclusion criteria)

  • Safety monitoring plan

• Create a clinical development plan (Phase 1–3)

• Draft Investigator’s Brochure (IB) (initial version)

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5. Regulatory Affairs and FDA Engagement

• Request a Pre-IND meeting (Type B)

• Submit a complete Pre-IND briefing package:

  • Cover letter

  • Table of contents

  • Product description

  • CMC summary

  • Nonclinical summary

  • Clinical plan and draft protocol

  • Specific questions to FDA

• Use the CDER pre-IND template (if applicable)

• Schedule a pre-meeting teleconference internally to align

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6. Quality and Documentation

• Set up a document management system (DMS)

• Prepare electronic Common Technical Document (eCTD) structure (for IND)

• Define roles and responsibilities for team members

• Draft a risk register for early development issues

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7. Other Supporting Activities

• Orphan Drug Designation, if applicable

• Investigate expedited pathways (e.g., Fast Track, Breakthrough)

• Ensure compliance with FDA guidance for the indication/class

• Identify consultants or CROs if outsourcing is needed

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🔁 Optional but Helpful

• Mock FDA Q&A session with external consultants

• Scientific advice from EMA or other regulatory agencies

• Initial publications or white papers (if de-risking is needed)

• Initiate IND-enabling studies (timing dependent)

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🗂️ Key Documents to Prepare

• Pre-IND meeting request letter

• Pre-IND briefing document

• Draft Investigator’s Brochure (IB)

• Draft Clinical Protocol (Phase 1)

• Nonclinical summary

• CMC summary

• Regulatory strategy document

• Slide deck for internal prep or investor review