regulatory strategy, project management, & more

Industries We Serve:

Biologics

Here’s How We Can Help

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

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Monoclonal antibodies
Therapeutic proteins
Cell & gene therapies
DNA & mRNA products
Microbiome therapeutics
Vaccines
Lipid-nanoparticles

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

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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View More Resources from Global

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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