global eCTD publishing and submissions services

PROJECT MANAGEMENT, TRAINING, GLOBAL ECTD PUBLISHING AND SUBMISSIONS SERVICES

Additional Services

We tailor our services to meet the unique needs of each client, providing flexible and scalable solutions. Our expertise ensures that your products comply with international regulations, streamline submissions processes, and achieve market success.

Navigate the complexities of regulatory submissions with confidence

At GLOBAL, we recognize that regulatory submissions are about ensuring accuracy, compliance, and efficiency every step of the way. Through our GLOBAL eCTD publishing and submissions services, we provide the expertise, tools, and guidance needed to streamline the process, reduce risks, and keep your projects moving forward.

eCTD Publishing

Our dedicated publishing team leverages deep technical knowledge and industry-leading tools to efficiently prepare, validate, and deliver compliant eCTD submissions.

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Submission Management

We combine regulatory expertise with hands-on project experience to oversee submissions from start to finish, ensuring accuracy, timeliness, and quality.

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Project Management

GLOBAL’s project managers optimize schedules, resources, and deliverables to reduce risk, improve efficiency, and keep complex submission portfolios on track.

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Training & Education

We provide customized training programs and mentorship to build internal expertise, equipping your team to confidently produce compliant, high-quality regulatory documents.

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EXPERTS IN GLOBAL ECTD PUBLISHING AND SUBMISSIONS SERVICES

Why Choose GLOBAL

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.

global eCTD publishing and submissions services

Proprietary AI Tools to Streamline Regulatory Process

global eCTD publishing and submissions services

Solution-Focused Approach that Alleviates Regulatory Pressure

global eCTD publishing and submissions 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.

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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.

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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.

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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.

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regulatory writing services for medical devices and IVDs
regulatory writing services

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