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
CMC Challenges in Cell & Gene Therapy: How to Avoid Regulatory Delays
In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable. Yet, while the science is groundbreaking, the CMC (Chemistry, Manufacturing, and Controls) pathway remains one of the most significant obstacles to timely regulatory approval.
Why BLAs Are Different from NDAs
When it comes to bringing new therapies to patients in the U.S., two key FDA pathways are often discussed: New Drug Applications (NDAs) and Biologics License Applications (BLAs). While both serve the same ultimate goal—getting safe and effective treatments to market—they follow very different paths. Understanding the differences between NDAs and BLAs is crucial for companies developing new therapeutics, particularly as the biotech landscape continues to evolve.
