The Latest from Kivo
Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.
How to Track Regulatory Correspondence in Kivo
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...
![Picture of Jianna Lieberman](https://kivo.io/hs-fs/hubfs/1557843014675.jpg?width=30&name=1557843014675.jpg)
How to Review and Approved Controlled Documents in Kivo
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...
![Picture of Jianna Lieberman](https://kivo.io/hs-fs/hubfs/1557843014675.jpg?width=30&name=1557843014675.jpg)
How to Manage Projects Efficiently with Automated Reporting
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...
![Picture of Jianna Lieberman](https://kivo.io/hs-fs/hubfs/1557843014675.jpg?width=30&name=1557843014675.jpg)
A Guide to Regulatory Submissions in the US (FDA) & EU (EMA)
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...
![Picture of Jianna Lieberman](https://kivo.io/hs-fs/hubfs/1557843014675.jpg?width=30&name=1557843014675.jpg)
How to Manage Regulatory Projects and Content Plans in Kivo
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...
![Picture of Jianna Lieberman](https://kivo.io/hs-fs/hubfs/1557843014675.jpg?width=30&name=1557843014675.jpg)
An Overview of ICH Guidelines
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...
![Picture of Jianna Lieberman](https://kivo.io/hs-fs/hubfs/1557843014675.jpg?width=30&name=1557843014675.jpg)
Recent FDA News: End of 2023 Summary
Happy new year folks!
![Picture of Theresa Pinnell](https://kivo.io/hs-fs/hubfs/1663683330999.jpg?width=30&name=1663683330999.jpg)
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...
![Picture of Toban Zolman](https://kivo.io/hs-fs/hubfs/Toban_Headshot.jpg?width=30&name=Toban_Headshot.jpg)
Kivo GO: 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...
![Picture of Toban Zolman](https://kivo.io/hs-fs/hubfs/Toban_Headshot.jpg?width=30&name=Toban_Headshot.jpg)
Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application
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.
![Picture of Theresa Pinnell](https://kivo.io/hs-fs/hubfs/1663683330999.jpg?width=30&name=1663683330999.jpg)
How To Implement a RIM System: Part 1
RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products...
![Picture of Theresa Pinnell](https://kivo.io/hs-fs/hubfs/1663683330999.jpg?width=30&name=1663683330999.jpg)
Everything You Need to Know About eCTD 4.0
If you have been in the industry as long as some of us, (haha) then eCTD v. 4.0 has been coming for a long time. 😉 Some agency regions are already accepting and piloting v. 4.0. For many...
![Picture of Theresa Pinnell](https://kivo.io/hs-fs/hubfs/1663683330999.jpg?width=30&name=1663683330999.jpg)