Pre-IND CMC Checklist For Regulatory Success

Preparing Chemistry, Manufacturing, and Controls (CMC) documentation for a Pre-IND submission is a critical step in accelerating early clinical development. This infographic outlines the key components of a well-structured CMC package, emphasizing how to align with regulatory expectations and avoid common pitfalls that can delay review timelines. From drug substance characterization to manufacturing process details and stability data, each element plays a role in demonstrating product readiness and quality. Whether you're advancing a small molecule or biologic, understanding what regulators look for—and when—is essential for a smooth transition into first-in-human studies.

If you're looking to strengthen your CMC strategy and ensure your submission is complete and compelling, gain practical insights to help you move forward with confidence.