Get a Demo

1 min read

How to Track Regulatory Correspondence in Kivo

Featured Image

Tracking agency commitments is essential for obvious reasons, but can be stressful without a system or process to manage them. With Kivo's Correspondence Tracking, you'll never have to worry things are falling through the cracks. Let's take a look at how it works! 

To start, we'll navigate to Regulatory Activity.

newsletter_Aug2024_step0

There are many types of Regulatory Activities that you can log in Kivo, including Applications, Submissions, and Products. But for this article, we'll select Correspondence

newsletter_Aug2024_1.1

Once you select the Subtype, you'll add a description. Kivo will automatically create the formatted name based on your SOPs. Click "Create"! 

newsletter_Aug2024_step2

Once you've created the activity, you can enter all the relevant information & metadata such as the Health Authority, the point of contact, the Related Application, and Due Date. But that's not all! Each piece of correspondence has to be logged in the DMS, so let's do that next.  

newsletter_Aug2024_step3

Scrolling down, you'll see a Related Content section. (You can also associate the Correspondence with a Project, such as an IND or CAPA, but we'll skip that for now.) This is where the magic happens. Click on "Add to Cabinet" and Kivo will automatically create the folders and document placeholders for your correspondence

newsletter_Aug2024_step4

Here's what that looks like once you Add to Cabinet. And each of these links directly to the document and placeholder in the DMS!

newsletter_Aug2024_step5-1

 With a simple drag and drop, you can add the source file of the email (including attachments!), and then view it at any time by clicking on Source.  

newsletter_Aug2024_step6

Finally, you can use all the metadata you added to track your correspondence in the Correspondence Log! You can access the log from the Reports module. You can filter by ApplicationAuthority, or Due Date, and you can schedule delivery of the report to your inbox with a couple clicks! 

newsletter_Aug2024_step7-1

TL;DR: never stress about missing a response again. And build an inspection-ready audit log while you're at it.

All thanks to a little auto-magic 🔮🪄✨

Anyhow, check out our full suite of regulatory capabilities in our clickthrough demo here. And if you'd like to learn more about how Kivo can help reduce manual tracking for you and your team, get in touch!

PMA Submission Guide: FDA Requirements, Timelines, and Best Practices

For medical device manufacturers, the Premarket Approval (PMA) process is the most rigorous path to market in the United States. Reserved for Class III devices that sustain life, prevent...

1 October 2025
7 min read

Biologics License Application (BLA) Guide For Life Sciences Teams

A Biologics License Application (BLA) is one of the most critical milestones in the development of a biologic therapy. It is the formal request submitted to the U.S. Food and Drug...

1 October 2025
8 min read

ANDA Application Guide For Modern Life Sciences Teams

Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to market is not a simple process. Companies must demonstrate that their...

30 September 2025
4 min read

PMA Submission Guide: FDA Requirements, Timelines, and Best Practices

For medical device manufacturers, the Premarket Approval (PMA) process is the most rigorous path to market in the United States. Reserved for Class III devices that sustain life, prevent...

1 October 2025
7 min read

Biologics License Application (BLA) Guide For Life Sciences Teams

A Biologics License Application (BLA) is one of the most critical milestones in the development of a biologic therapy. It is the formal request submitted to the U.S. Food and Drug...

1 October 2025
8 min read

ANDA Application Guide For Modern Life Sciences Teams

Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to market is not a simple process. Companies must demonstrate that their...

30 September 2025
4 min read