Life-changing Treatments Deserve the Best Regulatory Writing Services & Documentation
Who is GLOBAL?
We provide regulatory writing services, consulting, and technology solutions to help manufacturers bring products to patients at a life saving pace. From pre-market guidance to post-market maintenance, GLOBAL is your drug and device regulatory partner every step of the way
Making an Impact Since 2018
Deliverables
Where Innovation Meets Excellence.
GLOBAL combines experts and cutting-edge technology.
We know what you're up against: tighter budgets, limited resources, and unmoving deadlines. Add increased scrutiny from the regulatory bodies, and you're basically expected to work miracles. Well, now you can. GLOBAL regulatory experts and writers merge with our proprietary cutting edge technology powered by AI and machine learning to produce higher quality deliverables at a lower cost.
Proprietary AI Tools to Streamline Regulatory Process
Solution-Focused Approach that Alleviates Regulatory Pressure
Pre-market Guidance, Post-market Maintenance
Industries We Serve
Our Services
GLOBAL Resources
What is IVDR?
The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) is the European Union’s regulatory framework governing in vitro diagnostic medical devices—tests and instruments used to examine human samples like blood or tissue. For manufacturers, understanding the IVDR is essential for maintaining or gaining access to the EU market.
IND vs. NDA: Understanding the Difference in FDA Submissions
For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.
The FDA’s CMC Development and Readiness Pilot (CDRP) Program: What Sponsors Need to Know
In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program. This initiative is designed to help sponsors of certain accelerated development products better align their CMC strategies with the FDA early in the development process.
