Upsynergy

What Upsynergy does

Upsynergy is a private professional services firm headquartered in Fremont, California that provides a regulatory-to-market-entry gateway for Asian manufacturers seeking to sell health-related products in the United States. Its core offerings are organized around three service lines: (1) FDA regulatory compliance, including 510(k) premarket notification preparation and submission, ISO 13485 factory referrals for medical-device credibility, and complete multi-jurisdiction product registration packages; (2) cross-border client acquisition via China-side social network interaction and market-development sourcing of innovative products for the US market; and (3) US market launch via crowdfunding campaign management and new-media marketing that provides direct consumer feedback loops. The firm publicly cites 25 years of FDA regulatory experience and 65+ FDA approvals secured across medical devices, health foods, cosmetics, supplements, vitamins, and pharmaceuticals, with typical 510(k) cycles documented at roughly three months of FDA review following approximately two months of document preparation (often exceeding 500 pages).

The company is led by five founders — Jason Cheng (President), Simon Ding (VP of Operations), Peter Holmes (VP of Sales & Marketing), Winnie Ding (Campaign & Social Media Manager), and a fifth undisclosed co-founder — collectively bringing 50+ years of cross-functional experience spanning finance, business development, product/IT, and production/operations. Operating geographies span the United States, Taiwan, and China through dedicated regional offices and sales contacts, and the firm also assists clients with international distribution network setup across approximately 35-40 countries for products such as MedX Health Corp's laser therapy and skin cancer screening lines. Named reference clients include MedX Health Corp, Theradome Inc. (LaserCap), and REKA HEALTH Corp.

Commercially, Upsynergy operates an enterprise field-sales motion selling custom consulting engagements rather than disclosed pricing tiers or rate cards. Revenue streams flow from FDA regulatory service fees and business development/market-launch service fees, both classified as professional services revenue. The company is privately held with no disclosed institutional investors, funding rounds, or parent-company affiliation; a 'Starbis' entity appears in the website footer copyright but its relationship is uncharacterized. The firm has no disclosed patents, trademarks, awards, or partnerships, and is not positioned as a technology platform.

Name

Upsynergy

Legal name

Upsynergy

Website

https://upsynergy.com

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

11–50 employees

Short description

Upsynergy is a Fremont, CA-based professional services firm that helps Asian health-product manufacturers obtain FDA approval and launch in the US via 510(k) submissions, ISO 13485 referrals, and crowdfunding-driven market entry.

Ownership category

akta.pro rank

Product category

Regulatory & Market Entry Consulting Services

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

Keywords

• FDA regulatory consulting
• Medical device registration
• Market entry services
• Regulatory compliance services
• International product distribution

Headquarters

HQ city

Newark

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. FDA Regulatory Services: Professional consulting services for FDA 510(k) submissions, product registration, and regulatory approval for medical devices, health foods, cosmetics, supplements, vitamins, and pharmaceuticals.
2. Business Development Services: Market entry consulting, sales and marketing launch services, crowdfunding campaign management, and international distribution network setup for Asian manufacturers.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Upsynergy acts as a gateway service helping Asian manufacturers bring health, medical device, cosmetic, supplement, and pharmaceutical products into the United States. The company provides end-to-end market entry support including FDA regulatory submissions, 510(k) preparation, ISO 13485 quality system referrals, US crowdfunding and new media marketing, and international distribution channel setup.

Product overview

Upsynergy is a service company that provides a gateway for Asian manufacturers to market their products in the United States. The company operates as a unified service offering rather than a platform-plus-modules architecture. Its core portfolio consists of regulatory compliance services (FDA 510(k) Service and ISO 13485 Factory Referral), market entry services (China Social Network Interaction and USA Crowdfunding & New Media Marketing), and specialized business development for health-related products (FDA Registration Package and International Product Registration). These services work together to guide manufacturers from product approval through market launch and distribution.

Differentiator

Problem solved

Functional benefit

Products and services

• 510(k) Submission Service Preparation and submission of 510(k) premarket notification filings to the US FDA on behalf of medical device manufacturers seeking to enter the US market.
• ISO 13485 Factory Referral Referral service connecting manufacturers with ISO 13485 certified production facilities, enabling compliance with international medical device quality management standards.
• China Social Network Interaction Social media engagement and brand awareness service targeting Chinese consumer networks to support product visibility and market traction.
• USA Crowdfunding & New Media Marketing End-to-end execution of US crowdfunding campaigns and new media marketing strategies designed for Asian brands launching into American consumer markets.
• FDA Registration Package Comprehensive FDA product registration service for manufacturers of drugs, medical devices, cosmetics, food, and health products seeking US market authorization.
• International Product Registration Cross-border regulatory registration support to enable product commercialization across multiple international markets.
• Business Development for Health Products Strategic business development service supporting health product brands in establishing US commercial operations, distribution, and growth.

Quantifiable outcome

• FDA approval success for 65+ companies
• +2 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators6 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Eurofins Scientific: Global testing and regulatory services group that supports pharma, medical device, and consumer health product approvals, including FDA-related testing that anchors Upsynergy's 510(k) packages.
• IQVIA: Large life-sciences services firm offering regulatory, clinical, and commercialization support for pharma and medical device companies globally; overlaps with Upsynergy at the broader regulatory/launch level.
• Cardinal Health (regulatory and consulting services): Large healthcare distributor and services company that, through its broader portfolio, supports medical product manufacturers with regulatory and commercialization services overlapping Upsynergy's gateway offering.

Direct peers

• The FDA Group: Specialist FDA regulatory consulting and staffing provider for medical device and pharma companies, comparable to Upsynergy's regulatory submission and compliance services.
• Registrar Corp: FDA compliance and product registration services for foreign manufacturers selling into the US, including facility registration, listing, and U.S. Agent services, directly comparable to Upsynergy's US-market-entry gateway.
• NAMSA: Medical device-focused regulatory, testing, and consulting firm that helps manufacturers obtain FDA and international approvals, directly overlapping Upsynergy's 510(k) and ISO 13485 service line.
• MEDIcept: Medical device regulatory affairs, quality systems, and clinical consulting firm supporting FDA submissions and international approvals for manufacturers.
• FDAImports.com (Customs and Trade Solutions): Cross-border FDA import compliance and customs consulting firm assisting foreign manufacturers with US market entry, very close functional overlap with Upsynergy.

Regional players

• Vigene Biosciences: US-based CDMO and regulatory services firm focused on gene and cell therapy; serves a different therapeutic niche but uses a similar manufacturer-side FDA regulatory and commercialization model.

Emerging players

• Crowdfund Productions: Niche agency helping consumer health and wellness brands run regulated crowdfunding and product launch campaigns in the US, comparable to Upsynergy's crowdfunding and new-media launch service.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 Upsynergy