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

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.

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."

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)

Globizz Corp.
970 W. 190th St., Suite 200, Torrance, California 90502, U.S.A.
1-310-538-3860
https://www.linkedin.com/company/globizz-corp/
Presscontact: Saaya Hirai
s.hirai@globizz.net

About
Globizz Corporation is a U.S.-based regulatory and business consulting firm established in 2005, specializing in assisting international companies-particularly from Japan, South Korea, India, and Europe-in entering and navigating the U.S. market. With headquarters in Torrance, California, and offices in Tokyo, Osaka, Seoul, Ahmedabad, and the San Francisco Bay Area, Globizz offers a comprehensive suite of services tailored to facilitate global market expansion.

***Company Overview***
Founded by Takahiro "Harry" Haruyama, Globizz Corporation was established to bridge the gap between international companies and the complex U.S. regulatory landscape. Recognizing that many foreign businesses struggled with U.S. regulations, Globizz set out to provide expert guidance to facilitate successful market entry and expansion.

***Core Services***
1. Regulatory Compliance Consulting
Globizz offers specialized consulting services to help companies navigate U.S. regulations, including:

>>FDA: Assistance with 510(k) submissions, GRAS certifications, facility registrations, and inspection readiness.

>>EPA: Guidance on environmental regulations for chemicals and pesticides.

>>USDA: Support for compliance with standards for food and agricultural products.

>>California Proposition 65: Expertise in state-specific regulations concerning hazardous substances.

2. U.S. Market Entry Support
Globizz aids foreign companies in establishing and expanding their presence in the U.S. through:

- Company formation and incorporation services.
- Business development and strategic planning.
- Sales and distribution network establishment.
- Mergers, acquisitions, and partnership facilitation.

3. Marketing Research
To inform business strategies, Globizz conducts comprehensive market analyses, including:

- Feasibility studies and market entry assessments.
- Competitor analysis and benchmarking.
- Consumer behavior and demand forecasting.

***Recognition and Chievements***
"Top Medical Device Consulting Company" by MedTech Outlook (2020, 2021)
"Top 50 Innovative Companies of the Year" by CIO Bulletin

***Global Presence***
Globizz maintains a strong international presence with offices in:

- United States: Torrance, California (Headquarters); San Francisco Bay Area.
- Japan: Tokyo; Osaka.
- South Korea: Seoul.
- India: Ahmedabad.

This global footprint enables Globizz to provide localized support and cultural understanding in its consulting services.

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

This release was published on openPR.