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
Proposed Changes to EU MDR: What Manufacturers Need to Know
The European Commission has proposed a series of updates to the EU Medical Device Regulation (MDR) aimed at improving efficiency, reducing burden, and addressing long-standing bottlenecks—particularly around Notified Body capacity, classification clarity, and clinical requirements.
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.
