Workbook 4: Planning Your IND Strategy and Regulatory Pathway

This workbook shows you how to plan a compelling IND strategy and engage with the FDA with confidence. You’ll map out your Pre-IND meeting, assess readiness across preclinical, CMC, and clinical domains, and explore regulatory designations like Fast Track and Orphan Drug. Practical worksheets help you align timelines, prepare your briefing package, and position your program for long-term success. Your IND isn’t just a submission — it’s your biotech’s first impression.