regulatory consulting services

Consulting strategies tailored to your needs

Consulting Services

Don’t fear regulatory milestones. GLOBAL’s regulatory consulting services help you navigate the path from concept to approval with clarity and confidence. With decades of experience guiding drugs, biologics, devices, IVDs, and combination products through the regulatory process, we’ve supported hundreds of companies in meeting the highest compliance standards. Our deep industry knowledge, proactive guidance, and proven risk management strategies keep your development programs on track and positioned for success.

Our Regulatory Consulting Services

We provide specialized regulatory consulting services designed to address the unique challenges of your product and market. Explore our core service areas to learn how we can support your goals.

Clinical/Non-clinical Strategy

We partner with your team to deliver data-driven regulatory and clinical writing services, including authoring, editing, QC, publishing, and project management, ensuring clear, compliant, and accessible documentation for regulators, clinicians, and patients alike.

learn more

EU MDR Consulting Services

Navigate European Medical Device Regulation requirements with strategic guidance, compliance tools, and proven expertise.

learn more

Regulatory Affairs and CMC Services

Get expert support for CMC regulatory consulting, technical guidance, and quality systems that ensure your product’s success from development through approval.

learn more

Why Choose GLOBAL for Regulatory Consulting Services

At GLOBAL, our regulatory consulting services combine technical expertise with strategic insight to help you meet regulatory expectations efficiently and effectively. Our team’s collaborative approach ensures every submission, strategy, and compliance measure is aligned with your product’s unique needs and therefore reducing risk, streamlining timelines, and improving your likelihood of approval.

regulatory consulting services

Proprietary AI Tools to Streamline Regulatory Process

regulatory consulting services

Solution-Focused Approach that Alleviates Regulatory Pressure

regulatory consulting services

Pre-market Guidance, Post-market Maintenance

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.

READ MORE
regulatory writing services for medical devices and IVDs
regulatory writing services

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.

READ MORE
regulatory writing services for medical devices and IVDs
regulatory writing services

Biologics

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

READ MORE
regulatory writing services for medical devices and IVDs
regulatory writing services

Medical Devices/IVDs

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

READ MORE
regulatory writing services for medical devices and IVDs
regulatory writing services

Let’s Work Together

BOOK CONSULTATION