COMPREHENSIVE EXPERTISE TO NAVIGATE REGULATORY COMPLEXITIES

Industries We Serve:
Regulatory Expert Consulting

Lose the stress and anxiety as you venture into the unfamiliar. With GLOBAL, you can tackle regulatory pain points head on with confidence.

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.

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.

Delivering Regulatory Services that Make a Real Difference.

Regulatory Writing

Our experienced in-house writers deliver precise, compliant, and high-quality regulatory documents. We offer a full suite of writing services to cover all your document needs.

Clinical/Non-Clinical

Medical Devices

CMC Regulatory, Technical and Quality

In-Vitro Diagnostics

Consulting Services

Our team's deep industry knowledge and regulatory expertise help you navigate the complex requirements and optimize your regulatory strategies.

Regulatory Affairs and CMC Services

EU MDR Consulting Services

Clinical/Non-clinical Strategy

Additional Services

We tailor our services to meet the unique needs of each client, providing flexible and scalable solutions.

Training & Education

Project Management

Submission Management

eCTD Publishing

Let’s Get Started

GLOBAL provides trusted regulatory consulting , writing, and technology solutions to help manufacturers bring products to patients at a life saving pace. We’ll be with you every step of the way.

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