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...
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...
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...
NDA Application Guide for Life Sciences Teams
The goal of an NDA application is to present a clear, defensible story across CMC, nonclinical, clinical, and labeling so reviewers can evaluate benefit and risk without searching for...
De Novo Submission Guide: FDA Pathway Guide for Medical Devices
If you’re developing a new medical device and there’s no clear predicate on the market, you may be wondering whether the FDA’s De Novo pathway is the right route forward. The process can...
Clinical Trial Application (CTA) Guide for Biopharma and Medtech Teams
Launching a clinical trial outside the United States requires more than a strong protocol. It requires regulatory approval in the form of a Clinical Trial Application (CTA).
All About 21 CFR Part 11 Compliance
What is 21 CFR Part 11?
21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that sets the criteria for electronic records and electronic signatures...
How to Manage Projects Efficiently with Automated Reporting
One of the more challenging aspects of clinical trial management is visibility. The sheer number of outsourced partners - sites, CROs, writers, consultants, vendors, etc - who often have...
An Overview of ICH Guidelines
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or simply ICH, stands as a cornerstone in the realm of pharmaceutical development...
Webinar: Compliant Trial Master File Management & Migration in 2024
For many small and mid-size Clinical teams, the TMF struggle is real. Maybe you’re using your CRO’s eTMF for now - but what happens after study completion? Or maybe you’re trying to save...
TMF Breakdown: What Constitutes a Trial Master File?
At the heart of clinical trial documentation lies the Trial Master File (TMF), a comprehensive repository of essential documents and data pertaining to the trial. Let’s discuss this...