CUSTOMIZED COLLABORATION, PROBLEM SOLVING, & INDUSTRY EXPERTISE

Life-changing Treatments Deserve the Best Regulatory Writing Services & Documentation

IN VITRO DIAGNOSTICS

MEDICAL DEVICES

BIOLOGICS & BIOSIMILARS

DRUGS & GENERICS

COMBINATION PRODUCTS

SOFTWARE SOLUTIONS

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

regulatory writing services by Global RWC

Making an Impact Since 2018

40+

BLAs

60+

INDs

2400+

EU MDR
Deliverables

65+

Employees

Where Innovation Meets Excellence.

Streamlined Strategy & Support

A new discovery is just the beginning. It takes a steadfast team to advance your product from bench to bedside and keep it there. There may be obstacles along the way; GLOBAL experts can formulate, support, and streamline your approach.

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Delivering Excellence

Solutions to regulatory hurdles and workflow challenges are what GLOBAL lives and breathes. We meet our clients where they are and take them to where they want to be, exceeding their expectations along the way

see our work

STOP TRYING TO SOLVE INDUSTRY-WIDE PROBLEMS WITH THE SAME OUTDATED SOLUTIONS.

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

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COMPREHENSIVE EXPERTISE & REGULATORY WRITING SERVICES TO NAVIGATE REGULATORY COMPLEXITIES

Industries We Serve

Combination Products

Whether you’re entering the market as a wearable delivery device or converting your vial into a pre-filled syringe, combination device documentation requirements are rigorous. We’re here to help.

regulatory writing services for medical devices and IVDs

Small Molecules

While drug formulations and mechanisms of action change over time, submission data and documentation requirements remain unwavering. Our CMC, regulatory strategists, and project managers can help.

Biologics

GLOBAL has rich industry experience to provide you with the highest quality medical, regulatory, and technical writing, strategies, and project management.

Medical Devices/IVDs

Dedicated to supporting your regulatory and compliance needs with a comprehensive suite of services.

Our Services

Regulatory Writing

In-Vitro Diagnostics

CMC Regulatory, Technical and Quality

Medical Devices

Clinical/Non-Clinical

Consulting Services

Clinical/Non-clinical Strategy

EU MDR Consulting Services

Regulatory Affairs and CMC Services

Additional Services

eCTD Publishing

Submission Management

Project Management

Training & Education

GLOBAL Resources

Recent Blogs

What Is an NDA?

For sponsors developing new therapies, one of the most critical milestones on the regulatory pathway is preparing and submitting a New Drug Application (NDA). While biologics require a Biologics License Application (BLA), small-molecule drugs follow the NDA process.

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What Is a BLA?

The BLA is more than just an administrative step. It is the culmination of years of research, development, manufacturing, and clinical testing, and it represents the sponsor’s formal request that the FDA approve a biologic for commercial distribution in the United States.

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Writing High-Quality CSRs: Common Pitfalls and How Expert Support Can Help

Whether you’re submitting to the FDA, EMA, or another authority, the CSR must tell a clear, compliant, and credible story of your trial. GLOBAL's Medical Writing team shares tips and tricks to get it right.

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Combining Experts & Cutting-Edge Tech

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