Regulatory Operations Strategic Consulting
Articles of interest to Regulatory Operations professionals and people working on eCTD submissions.
Nothing gives a RegOps professsional the blues like working on a submission the last week of Dec. Here are suggestions to avoid that situation this year.
Module 3 is usually the most complicated part of an eCTD submission for Regulatory Operations. This post describes ways to improve the process.
Regulatory Operations roles in strategic biopharmaceutical partnerships include due diligence, setting up collaboration platforms, and managing document reviews
The right approach to managing submission projects can minimize stress by outlining the process and identifying the key handoff points between functions
The last step before an eCTD submission goes to the regulatory agency is for authors to QC the submission to ensure that content and formatting are correct
FDA reviewers consistently ask for better eCTD leaf titles. Here's why they care, and how you can improve leaf titles in your eCTD submissions.
It's hard for most people to grasp important eCTD concepts like lifecycle and granularity. Using an eCTD viewer is the best way to help them learn.
The eCTD allows study reports in either legacy or granular format. This post discusses advantages of each approach and outlines a strategy for sponsors.
Implementing FDA's fillable forms for eCTD submissions is not always easy, but doing so will get submissions to reviewers more quickly.
Responding to FDA questions can be a challenge in the eCTD world. Ignoring eCTD lifecycle management can lead to difficulties down the line.
In the eCTD world, hyperlinks can be helpful, but they are costly to implement. Too many hyperlinks can make documents hard to read.
Copyright © 2016 Aerie Canal Consulting, LLC.All photographs Copyright © Monte Levinson