An IND submission is the culmination of years of discovery, experimentation, and refinement; the point where hundreds of data points, experiments, and insights are distilled into a single, coherent story for the FDA.

This blog explores the file formats accepted by the FDA, the common pitfalls of working with non-PDF documents, and best practices for ensuring your submission is compliant, efficient, and fully reviewable.

Managing, compiling, and creating a marketing application in the pharmaceutical, biotech, and medical device industries is a complex,...

By Allison Steffen The submission of a marketing application, whether a New Drug Application (NDA) or a Biologics License Application...