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Kivo News

Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.

Regulatory

10 min read

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.  

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6 min read

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 across the life sciences value chain. RIM systems encompass business...

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7 min read

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 emerging and smaller pharma, you may be questioning "what’s in it...

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2 min read

eCTD Version 4.0 - The What, Why, Who, and When

The Electronic Common Technical Document (eCTD) has long been the backbone of regulatory submissions, streamlining the process of dossier submissions for marketing authorization applications. As the landscape of life sciences continues to evolve, so...

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5 min read

How to Choose an EDMS for Regulatory Information Management

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 streamline and organize regulatory information, ensuring access...

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5 min read

What is an eCTD Viewer?

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 Common Technical Document (eCTD) viewer. An eCTD viewer allows users...

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5 min read

SharePoint vs RIM: When to migrate to a Compliant RIM System

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 wrestling with the same challenges. 

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1 min read

Submit documents faster with Kivo’s ICH authoring packages

Emerging life science organizations often deal with authoring processes that are lengthy and complicated. Documents are difficult to format and maintain, and users often spend the bulk of their time figuring out what content is expected by a health...

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