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A few months ago, we announced our partnership with Vistatec Life Sciences. This partnership delivers integrated, accurate, translated regulatory writing combined with expert localization expertise that helps organizations accelerate global submissions with clarity, confidence, and compliance.
Vistatec Life Sciences and GLOBAL have worked together on client projects for many years. This formalized partnership takes that proven working relationship and structures it into something clients can rely on from the outset.
As our clients and partners know, GLOBAL brings deep regulatory expertise to the table. Our in-house team of specialist writers produces clinical, regulatory, and GMP documentation at every stage of the product development lifecycle. This includes pre-market submissions, post-approval maintenance, and everything in between. We work across both drug and device categories, with particular strength in areas like 510(k) submissions, IND/NDA filings, and EU MDR compliance.
Vistatec Life Sciences complements this with multilingual regulatory precision at scale. Their portfolio spans medical devices, clinical trials, biotechnology, pharmaceuticals, health care software, and mental health. Vistatec’s localization expertise ensures that regulated content can move confidently across languages, regions, and regulatory authorities. Furthermore, Vistatec’s quality and governance-ready translations mean fewer surprises during regulatory review.
Together, we make a world-class regulatory writing and localization partnership.
What Clients Can Expect:
The partnership delivers four tangible benefits for life sciences organizations.
Faster time to market
When writing and translation workflows are aligned, downstream delays shrink. Content moves through the pipeline more efficiently, and regulatory approval timelines tighten as a result.
Fewer review cycles
Regulatory authorities expect clear, accurate, and consistent documentation. When writing and localization teams work from the same foundation, the content is more likely to meet those standards on the first pass.
Reduced operational and regulatory risk
End-to-end support across content creation, translation, and compliance minimizes the inconsistencies that can lead to regulatory pushback or costly delays.
Future-ready operations that grow with you
The life sciences industry is moving toward digital-first regulatory models, and this partnership is designed to support that transition. Whether a company is filing a single submission or managing a global portfolio, the framework grows to meet the need.
Technology That Supports the Partnership
GLOBAL’s commitment to modernizing regulatory work extends beyond writing and consulting. Through GxT (Global Exponential Technologies), their dedicated technology brand, GLOBAL develops AI-powered tools purpose-built for regulatory professionals.
RegWriter™, for example, is an AI-augmented document authoring platform designed to accelerate submission preparation, improve authoring efficiency, and maintain full audit-trail transparency. Similarly, SmartComplaints™ uses machine learning to automate the categorization of post-market complaints against IMDRF Annex codes. These tools follow the same philosophy that drives the partnership itself. They combine deep domain expertise with practical technology to accelerate and improve the reliability of regulatory work. Explore GxT’s full product suite at www.globalxt.io.
Check out the recent webinar we co-presented discussing AI in the regulatory industry. (GET LINK)
Vistatec Life Sciences and GLOBAL have been collaborating for many years, and this partnership solidifies the trust and cooperation we have built. We have delivered a podcast and webinar together this year and look forward to more connections through thought leadership and knowledge sharing.
Listen to the Vistatec Podcast with Julie Moon.
We know our partnership will benefit our shared clients with a positive impact on submission timelines, a reduction in risks, and a pathway to achieve regulatory success.
Connect today to discuss how this partnership can benefit your organization today!
A few months ago, we announced our partnership with Vistatec Life Sciences. This partnership delivers integrated, accurate, translated regulatory writing combined with expert localization expertise that helps organizations accelerate global submissions with clarity, confidence, and compliance.
The European Commission has proposed a series of updates to the EU Medical Device Regulation (MDR) aimed at improving efficiency, reducing burden, and addressing long-standing bottlenecks—particularly around Notified Body capacity, classification clarity, and clinical requirements.
The 510(k) pathway may be well established, but success depends on precision and clarity. With deep experience across medical device categories and FDA submission types, our team at GLOBAL helps you bring safe, effective technologies to patients—faster and with confidence.
