Resource Library

Tracking agency commitments is essential for obvious reasons, but can be stressful without a system or process to manage them. With Kivo'sCorrespondence Tracking,you'll never have to...

Document authoring is one of the most essential activities in Regulatory, Clinical, and Quality operations. Regulations such as CFR Part 11 requiring compliant e-Signatures dictate the way...

One of the more challenging aspects of clinical trial management is visibility. The sheer number of outsourced partners - sites, CROs, writers, consultants, vendors, etc - who often have...

If you're new to regulatory submissions, they can seem a little confusing - and not just because there are some many acronyms to learn. To help you navigate the landscape, we offer this...

Regulatory content planning is a foundational step for any regulatory submission. A regulatory content plan is a outline of the pieces of content required for the submission, their due...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or simply ICH, stands as a cornerstone in the realm of pharmaceutical development...

Happy new year folks!

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...

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...

In this article, we'll walk you through what an IND is, what the application should include, and how to work alongside the FDA for maximum success.