The Latest from Kivo

As discussed in our previous post, Kivo GO represents a huge step forward for collaboration across Regulatory, Clinical, and Quality functions. Obviously, this wouldn’t be possible without...

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...

Announcing Kivo GO: An intuitive DMS to accelerate speed-to-market for life sciences

September 26, 2023

How Hyloris Scaled Regulatory, Clinical, and Quality Operations with Kivo GO

The Challenge

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...

With numerous eTMF software options available in the market, selecting the right system for your organization can be a daunting task. In this article, we will walk you through the key...

Throughout the clinical trial, the majority of sponsors delegate responsibility for management of their most valuable asset to their CRO. That most valuable asset is the Trial Master File...

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...