Resource Library

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).

Life sciences companies face some of the strictest regulatory environments in the world. From FDA and EMA oversight to global standards like ISO 13485 and GDPR, compliance requirements...

Bringing a medical device to the U.S. market is rarely simple. Teams face a maze of regulatory pathways, and for new teams working on their first development cycle, the 510(k) submission...

If you work in regulatory affairs, you know how complex submissions have become.One product might require dozens of sequences across multiple regions, each with unique formatting, timing,...

Regulatory lifecycle management (RLM) transforms compliance from a reactive burden into a strategic advantage. Companies with effective RLM processes scale faster into new markets while...

In life sciences, it's easy to overlook correspondence. Between protocols, submissions, validation plans, and controlled documents, emails and message threads can feel like background...

SOP drift. Duplicate files. Missed periodic reviews. Failed audits. These are all symptoms of a document management process that isn't built for regulatory rigor.