Bringing a new therapy to market in the European Union requires years of work across research, development, and compliance.

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...

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...

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...

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...

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...

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).

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...

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...

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...

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...