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medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Responsible AI in Medical & Regulatory Writing: Why Expert Oversight Matters

Generative AI tools are starting to revolutionize how many industries engage with regulatory obligations. We discuss the opportunities and challenges in working with AI, and outline how our team of medical writers can support your project to ensure quality submissions.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

The Challenges of Using AI for Medical Device Adverse Event Categorization & Reporting and How to Overcome Them

Explore challenges with AI in the medical device industry and explore practical solutions.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Overcoming the Challenges of Complaint Reporting with IMDRF Adverse Event Terminology

The IMDRF framework offers a solution to challenges associated with complaint reporting by providing a standardized set of terminologies for adverse event reporting, streamlining processes, and improving the accuracy of reported data.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Far UV C and Coronavirus Disinfection News in 2024

Research is growing in the area of rapid, safe limitation of airborne and surface viral transmissions, and one usage is a type of ultraviolet (UV) light device for disinfecting surfaces and objects.

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

Artificial Intelligence AI and the Pharmaceutical Industry

According to a recent review in Drug Discovery Today leading pharmaceutical companies are in an ‘early mature’ phase of using AI in research & development (R&D). Learn more in this post!

medical device REGULATORY submissions
PHARMA & BIOLOGICS REGULATORY SUBMISSIONS
TECHNOLOGY
GLOBAL INSIGHTS
DEI IN REGULATORY WRITING

AI-Powered Submission Authoring for Module 3 and Beyond: Introducing RegWriter

How RegWriter™ can improve your regulatory submission process.

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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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