When most teams think about their investigational or marketing submission, they focus on compliance: Does it pass validation? Are all required documents included? Is the structure correct? These are critical questions, but they are not the only ones that matter. A more important question for consideration: Can an FDA reviewer easily find what they need, understand your data, and make a confident decision about your application? This shift in perspective from "technically comp

When smaller pharma and biotech organizations reach the point of regulatory submission planning, there’s often a pivotal decision to make: do we build an internal publishing capability or outsource?  On paper, growing the team internally seems logical, especially if there is a steady pipeline, experienced regulatory leads, or a desire to maintain direct control. In-house publishing can make sense when organizations have high submission volume, a stable pipeline, and a dedicat

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...

By Allison Steffen The DIA Regulatory Submissions, Information, and Document Management (RSIDM) Conference was held in February again...

For small and resource-constrained teams, outsourcing regulatory submission publishing can offer significant advantages.

The Electronic Common Technical Document (eCTD) has become the global standard for submitting regulatory information to agencies.

Thr Orange Book provides a comprehensive list of FDA-approved drug products and their therapeutic equivalence evaluations.

A detailed discussion of the clinical components in Modules 2 and 5 of the eCTD submission

This blog post will outline the structure and purpose of the nonclinical components of the eCTD.

Ever wonder how those harmonized guidelines that address the technical and scientific aspects of drug development come about? The...

Allison Steffen The recent DIA Regulatory Submissions, Information, and Document Management (RSIDM) Conference offered many practical...

Module 3, dedicated to Quality (Chemistry, Manufacturing, and Controls), is an important yet complex component of the eCTD.

The FDA ESG NextGen will be scalable, secure, more user-friendly, and designed to handle the full spectrum of electronic submissions.

FDA Validator Rules are technical criteria and guidelines applied by the U.S. FDA during regulatory submission review.

An Investigational New Drug (IND) application is a critical step for companies aiming to test their new drug candidates in humans....

Part two of a series about FDA approvals. In Part 1, covered the approval framework. Part 2 covers accelerated approvals.

In the world of drug development, the Food and Drug Administration (FDA) approval holds immense significance. It represents a meticulous...