Recent FDA News: End of 2023 Summary
Happy new year folks!
How To Submit An Investigational New Drug (IND) Application
Last Updated: October 2026
An Investigational New Drug (IND) application is a mandatory regulatory submission that allows sponsors to legally ship and test experimental drugs or biologics...
How To Implement a RIM System
Last Updated: August 2026
How do you implement a RIM (Regulatory Information Management) system?
Implementing a RIM system means aligning your organization’s structure to a reference model,...
eCTD Version 4.0 - The What, Why, Who, and When
Last Updated: October 2026
What is eCTD 4.0, who does it affect, and when does it take effect?
What is an eCTD Viewer?
Last Updated: October 2026
What is an eCTD viewer?
An eCTD viewer is software that lets you open an electronic Common Technical Document (eCTD) submission the way a regulatory agency sees...
SharePoint vs RIM: When to migrate to a Compliant RIM System
Last Updated: October 2026
Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not...
How to Choose an EDMS for Regulatory Information Management
Last Updated: October 2026
How do you choose an EDMS for regulatory information management (RIM)? Start with your submission workload and team size, then insist on the compliance basics:...
Webinar: Managing IND Submissions Using Lean Principles
In this webinar, Kivo CEO Toban Zolman and Director of Regulatory Theresa Pinnell discuss how to apply Lean methodologies to the regulatory submission process, focusing on an IND submission...