Theresa Pinnell

Theresa Pinnell has worked with over 100 small to large pharma organizations over the last 20 years in support of regulatory operations, document management and software implementation projects to complete clinical trial and marketing applications. She began her career at Millennium Pharmaceuticals deploying and supporting Documentum for the functional areas of regulatory submission processing. Like, Toban, Kivo’s CEO, Theresa joined the regulatory software pioneering team at ISI where she inspired and advocated for the first IND in eCTD format to FDA project with her client, EPIX. This project led directly to the some of the early guidance on the IND eCTD mapping documentation. She brings her learnings with past clients, deep understanding of the RIM requirements and empathy for regulatory professionals to offer her observations.

10 min read

Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application

Theresa Pinnell: 8/30/23 4:30 AM

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.

Regulatory

6 min read

How To Implement a RIM System: Part 1

Theresa Pinnell: 8/16/23 6:30 AM

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...

Regulatory

7 min read

Everything You Need to Know About eCTD 4.0

Theresa Pinnell: 8/3/23 10:25 AM

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...

Regulatory

2 min read

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

Theresa Pinnell: 7/31/23 10:22 AM

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...

Regulatory

5 min read

How to Choose an EDMS for Regulatory Information Management

Theresa Pinnell: 7/20/23 6:30 AM

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...

Regulatory

5 min read

What is an eCTD Viewer?

Theresa Pinnell: 7/14/23 7:30 AM

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...

Regulatory

5 min read

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

Theresa Pinnell: 6/5/23 12:30 PM

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.

Regulatory