Kivo News

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.  

RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products...

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...

The Electronic Common Technical Document (eCTD) has long been the backbone of regulatory submissions, streamlining the process of dossier submissions for marketing authorization...

In the realm of regulatory submissions, ensuring efficient document management, accessibility, and compliance is paramount. One critical tool that aids in this process is an Electronic...

Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not alone. Many sponsors are...

In pharma and biotech, managing regulatory information effectively is crucial for compliance and success. An Electronic Document Management System (EDMS) provides a powerful solution to...