Globizz

What Globizz does

Globizz Corp. is a US-headquartered, founder-owned regulatory consulting firm that has specialized in FDA compliance and US market entry for Asian — primarily Japanese, Korean, and Indian — manufacturers of medical devices, pharmaceuticals, cosmetics, food products, and radiation-emitting equipment since its founding in May 2005 by Takahiro Haruyama (春山貴広) in Los Angeles. The company delivers a comprehensive service catalog spanning 510(k), De Novo, and PMA application support; FDA inspection preparation and mock audits; GMP/QSR quality system construction; Breakthrough Device Program (BDP) advisory; FDA cosmetics regulation under MoCRA; EPA/TSCA chemical compliance; California Proposition 65; market research; and end-to-end US market entry including M&A and contract negotiation. Service delivery relies on a bilingual Japanese-American consulting team, and the firm has institutional endorsement from the US Embassy/Select USA program, which has co-sponsored its annual medical device seminar for 12 consecutive years (2013–2025).

The business model is professional-services-based with three revenue streams: (1) project-based FDA consulting fees for individual submissions and engagements, (2) recurring monthly advisory contracts starting at $1,000/month that provide ongoing Q&A, newsletters, and regulatory updates, and (3) seminar and training program fees. Go-to-market is sales-led and relationship-driven, executed through direct enterprise engagement across the firm's multi-country office footprint — Torrance (US HQ, relocated June 2024), Tokyo, Osaka, Seoul, and Ahmedabad (India via the Isazi Pharma joint venture) — supplemented by participation in major industry exhibitions (MEDICA, KIMES, MEDTEC Japan), embassy-sponsored seminars, and digital content via LinkedIn, YouTube, Twitter/X, Facebook, and Instagram.

Name

Globizz

Legal name

Globizz Corp.

Website

https://globizz.net

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Globizz is a US-headquartered, founder-owned consulting firm providing FDA regulatory compliance and US market entry services to Japanese, Korean, and Indian medical device, pharmaceutical, cosmetics, and food manufacturers, delivered through offices in the US, Japan, Korea, and India.

Ownership category

akta.pro rank

Product category

Regulatory and Compliance Consulting

NAICS

Professional, Scientific, and Technical Services (54), Marketing Research and Public Opinion Polling (541910)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE)

akta.pro secondary industries

Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE), Training & Competency Programs for GxP Compliance (HLAGAKAM)

Keywords

• FDA regulatory consulting
• Medical device compliance
• US market entry support
• Pharmaceutical regulatory services
• Cross-border business consulting

Headquarters

HQ city

Torrance

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. FDA Consulting Services: Professional consulting fees for FDA regulatory services including 510(k) applications, facility registration, regulatory compliance consulting, and FDA inspection support.
2. Advisory Contract Services: Monthly advisory contracts starting from $1,000/month for ongoing regulatory consulting, question answering, and newsletter distribution.
3. Seminar and Training Services: Revenue from conducting seminars and training programs on FDA regulations, US market entry, and regulatory compliance topics.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Globizz is a US-Japan consulting firm that helps Asian (primarily Japanese, Korean, and Indian) companies obtain US regulatory approvals and enter the US market. Its core offerings include FDA regulatory consulting for medical devices (510(k), De Novo, PMA), pharmaceuticals, cosmetics (MoCRA), food (GRAS), radiation equipment, and EPA/Proposition 65 compliance, plus quality system construction (GMP/QSR/ISO 13485), FDA inspection preparation, US market research, and end-to-end US business establishment support. Services are delivered bilingually in Japanese, Korean, and English through offices in Torrance (US HQ), Tokyo, Osaka, Seoul, and Ahmedabad.

Product overview

Globizz is a US-Japan consulting firm specializing in FDA regulatory compliance and US market entry support for Japanese companies. The company offers a comprehensive suite of consulting services organized around FDA regulatory consulting (medical devices/510(k), pharmaceuticals, food/GRAS, cosmetics, radiation equipment, inspection support, EPA, and Proposition 65), US market entry consulting (sales support, marketing, business establishment, M&A, contract negotiation), market research, and ISO certification support. Services are delivered through offices in Los Angeles, Tokyo, Osaka, Seoul, and India, with a team of both American and Japanese regulatory experts providing bilingual support in Japanese and English.

Differentiator

Problem solved

Functional benefit

Products and services

• FDA Medical Device / 510(k) Consulting Consulting service that guides medical device manufacturers through FDA 510(k) premarket notification, registration, and US distribution requirements. Targeted at Japanese and Asian medical device companies seeking US market entry.
• FDA Pharmaceutical Consulting Regulatory research, FDA drug registration, application preparation, and inspection support for OTC and prescription pharmaceutical products entering the US market. Targeted at overseas pharmaceutical manufacturers.
• FDA Food / GRAS Consulting Consulting covering GRAS notification, FDA facility registration, FSMA compliance, food labeling, and animal product regulations for food, supplements, beverages, and pet food entering the US.
• FDA Cosmetics Consulting Consulting covering MoCRA compliance, facility registration, product listing, fragrance allergen and PFAS/ingredient review, and California Proposition 65 alignment for cosmetics manufacturers entering the US.
• FDA Radiation Equipment Consulting FDA registration, annual reporting, and ongoing regulatory compliance support for manufacturers of radiation-emitting devices selling into the US market.
• FDA Inspection Support End-to-end FDA inspection support covering schedule coordination with US FDA offices, on-site interpretation, and post-inspection response assistance for foreign manufacturers.
• Safety Testing / ISO Certification Support Safety testing and ISO certification support delivered through partnership with Japan Quality Assurance Organization (JQA), providing one-stop support for FDA applications and quality compliance requirements.
• US EPA Consulting

Quantifiable outcome

• Over 19 years of experience supporting foreign companies' FDA regulatory compliance and US market entry since 2005
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Hankook Research (Korea)coreStrategic or Co-development Partner · 28 May 2025Business partnership for FDA application medical device testing support. Hankook Research, Korea's largest research company, partnered with Globizz to help Korean medical device manufacturers overcome challenges with US testing including high costs and schedule management. Globizz leverages its strong US facility network to effectively manage these challenges.
• Samsung Medical Center - Smart Healthcare Research Institute Usability Evaluation CentercoreStrategic or Co-development Partner · 20 March 2025Globizz and Samsung Medical Center's Smart Healthcare Research Institute signed an MOU for supporting Korean medical device companies' overseas expansion and usability evaluation. The partnership focuses on FDA approval for Korean medical device companies and includes joint symposia and national research projects.
• Korea Testing Laboratory (KTL) - Korea Industrial Technology Research InstitutecoreStrategic or Co-development Partner · 25 January 2024Partnership under Korea's Ministry of Trade, Industry and Energy 'Medical Device Commercialization Promotion Project' for supporting Korean medical device manufacturers' overseas expansion. Collaboration formalized through a basic agreement signed in December 2023.
• Isazi Pharma and Techno Consultancy Pvt. Ltd. (India)coreStrategic or Co-development Partner · 4 June 2021Partnership for India market entry support. Isazi Pharma and Techno Consultancy is a pharmaceutical regulatory consulting company based in Gujarat, India. The partnership enables Globizz to provide consulting services for Japanese companies entering the Indian pharmaceutical and medical device market.
• Japan Quality Assurance Organization (JQA)coreImplementation/ SI/ Consulting Partner · 1 January 2015Comprehensive business partnership for ISO certification support. JQA provides safety testing, QSR construction advice, and ISO certification support services through the partnership, enabling Globizz to offer comprehensive quality system services to clients.
• US-Japan Medtech FrontiersminorGTM or Marketing PartnerNon-profit organization promoting US-Japan cooperation in medical devices. Globizz participates in annual symposia and events organized by this organization.
• Select USA / US EmbassycoreGTM or Marketing PartnerUS Embassy 'Select USA' program partnership. The US Embassy and Select USA co-sponsor Globizz's annual medical device seminars, providing official US government endorsement for the company's educational events.

Scale indicators3 records

Recent moves12 records

Expansion highlights6 records

Direct peers

• EMERGO by UL: EMERGO by UL is a global regulatory consulting firm specializing in medical device market access, with dedicated US-Japan and US-Asia practices. It is the most direct head-to-head peer to Globizz, offering 510(k), CE Marking, ISO 13485, and FDA submission services — overlapping directly on Globizz's core offering for Asian medtech manufacturers entering the US.
• Maetrics: Maetrics is a life sciences regulatory compliance consultancy providing FDA, ISO 13485, MDSAP, and EU MDR consulting. It is a direct peer on QSR/GMP compliance, mock inspections, and supplier qualification — areas that overlap with Globizz's FDA GMP/QSR system construction and inspection support services.
• RQM+: RQM+ is a regulatory and quality consulting firm focused on medical devices, offering FDA submission support, QMS implementation, and clinical regulatory services. It is a direct peer in the mid-market medical device regulatory consulting space where Globizz also competes for enterprise Asian clients.
• Medevise Consulting: Medevise Consulting is a boutique medical device regulatory and reimbursement consulting firm serving device manufacturers with FDA submissions and market access strategy. It is a direct peer in the medical device regulatory consulting niche where Globizz competes for mid-market and enterprise medtech clients.

Broad incumbents

• Intertek Japan: Intertek provides testing, inspection, and certification services globally, including medical device regulatory support and product safety testing. Comparable to Globizz on the ISO/QSR/medical device testing and certification side for Japanese manufacturers pursuing US market access.
• NAMSA: NAMSA is one of the largest medical device-focused CROs, providing regulatory, quality, and testing services globally. While significantly larger and US-centric, NAMSA's medical device regulatory consulting practice directly competes with Globizz on 510(k) and PMA engagements, particularly for Japanese and Korean clients seeking US entry.
• Hogan Lovells (FDA practice): Hogan Lovells is a global law firm with a leading FDA and medical device regulatory practice serving Japanese, Korean, and other international clients on US market entry. It is a comparable provider in the FDA regulatory services category, competing for the same large enterprise Asian medtech clients as Globizz.
• TÜV SÜD Japan: TÜV SÜD is a global testing, inspection, and certification (TIC) company with a Japan presence providing ISO 13485, MDSAP, and FDA-related certification support. Comparable to Globizz through its JQA partnership dynamic and as a one-stop regulatory/testing provider for Japanese medtech exporters — a scaled competitor in the same buyer workflow.

Regional players

• Korea Testing Laboratory (KTL): KTL is a Korean government-affiliated testing and certification body supporting medical device overseas expansion under Korea's Ministry of Trade, Industry and Energy program. It is both a Globizz partner (since 2024) and a comparable regional player providing FDA testing and certification support specifically for Korean medical device manufacturers.

Others

• JETRO (Japan External Trade Organization): JETRO is the Japanese government-affiliated trade promotion organization supporting Japanese companies' overseas expansion, including into the US market. While not a commercial competitor, JETRO frequently refers Japanese SMEs to consulting firms like Globizz, and Globizz's founder previously served as a JETRO overseas expansion coordinator — making it an adjacent ecosystem enabler in the same buyer journey.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/GlobizzC
• YouTubeyoutube.com/@globizzconsulting450
• Facebookfacebook.com/GlobizzCorp
• LinkedInlinkedin.com/company/globizz-corp
• Instagraminstagram.com/globizz.marketing

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Globizz