A Guide to Regulatory Submissions in the US (FDA) & EU (EMA)
Last Updated: October 2026
What are the main types of regulatory submissions in the US (FDA) and the EU (EMA), and how do they compare?
In the US, sponsors file an IND to begin clinical...
A Practical Guide To Regulatory Content Management
If your team has ever spent hours hunting for the “final-final” version of a regulatory document, only to realize it was never properly approved or stored, you're not alone.
An Overview of ICH Guidelines
Last Updated: October 2026
What are ICH guidelines? They are the harmonised technical standards for developing and registering medicines that the International Council for Harmonisation of...
Recent FDA News: End of 2023 Summary
Happy new year folks!
Kivo GO Feature Round Up: Regulatory Updates
Alongside the launch of our QMS, we’ve also made some big improvements to our regulatory management capabilities. In this article, we’ll outline what’s new and how those changes can...
Kivo Feature Round Up
Now that the dust has settled from the official launch (including our company retreat and two back-to-back conferences - whew!) we’re finally able to put pen to paper on what makes Kivo GO...
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,...
Everything You Need to Know About eCTD 4.0
Last Updated: October 2026
What is eCTD 4.0, and when do you need to switch?
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...