Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and more than $2 billion to successfully bring a new drug to market, and only 10 to 15 percent of products ultimately receive regulatory approval.
A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the development timeline and increase the likelihood of marketing success, especially for small biotech and specialty pharma companies working with limited time and resources. This document provides an overview of the critical planning activities and milestones in the drug development process and outlines important regulatory considerations at each stage.