The Californer - Globizz Expands Asia-Pacific FDA Support Through Strategic Partnership with Hankook Research

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Globizz, a global leader in FDA consulting, has signed a Memorandum of Understanding with Hankook Research, South Korea's largest research organization, to provide comprehensive services covering all aspects of FDA approval for medical devices.

TORRANCE, Calif. - Californer -- On the 26th, Globizz, a global leader in FDA regulatory consulting, signed a strategic Memorandum of Understanding (MOU) with Hankook Research Co., Ltd., South Korea's premier full-service market research organization. The agreement marks a significant step in delivering integrated services to medical device companies seeking U.S. FDA approval, combining Globizz's regulatory expertise with Hankook Research's world-class user experience (UX) and human factors evaluation capabilities.

Founded in 1978, Hankook Research is widely recognized as one of the most respected and established research institutions in Asia. The company provides in-depth insights across diverse sectors through advanced methodologies and digital tools. Its Innovation Division specializes in UX design research, human factors testing, and medical device usability evaluation—critical components for compliance with FDA human factors engineering requirements. With extensive experience in global studies, Hankook Research serves both domestic and multinational clients.

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The partnership will enable Globizz to offer a full spectrum of FDA consulting services that now include usability testing and user-centered design evaluations—vital steps for medical device manufacturers navigating premarket submissions. This collaboration is particularly valuable for clients across the Asia-Pacific region, including Korea, Japan, and India, who aim to bring innovative medical technologies to the U.S. market.

Takahiro Haruyama, CEO of Globizz, stated:
"By joining forces with Hankook Research, we are significantly enhancing our service offering for the Asia-Pacific region. Their Innovation Division brings deep expertise in usability evaluation, which is becoming a core regulatory requirement. Together, we can offer truly comprehensive support for medical device companies throughout the product lifecycle."

Mr. Kang Deok-yong, Head of the Innovation Division at Hankook Research, added:
"Our Innovation Division's Medical Device Usability Evaluation Center possesses excellent research capabilities and international experience, which give us a strong competitive edge not only in Korea but also across the Asia-Pacific region. With this MOU, Hankook Research has established global capabilities to offer professional services across the entire lifecycle of medical device development — from the very first steps to the final stages."

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Moving forward, the two companies plan to launch joint programs and customized consulting packages to help Asia-Pacific medical device firms overcome regulatory hurdles, enhance product safety and usability, and successfully enter the U.S. healthcare market.

Globizz FDA Consulting Website:
https://globizz.net/En/index.html (English)
https://globizz.net/index.html (Japanese)
https://globizz.net/Ko/index.html (Korean)