Recent FDA News: End of 2023 Summary
Happy new year folks!
How To Submit An Investigational New Drug (IND) Application
An Investigational New Drug (IND) application is a mandatory regulatory submission that allows sponsors to legally ship and test experimental drugs or biologics in human clinical trials in...
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...
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...
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...
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...
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...
Webinar: Managing IND Submissions Using Lean Principles
In this webinar, Kivo CEO Toban Zolman and Director of Regulatory Theresa Pinnell discuss how to apply Lean methodologies to the regulatory submission process, focusing on an IND submission...