What Asia Actual does

Asia Actual is a privately-held professional services firm that acts as the local regulatory representative for medical device and IVD manufacturers seeking market access across 16 Asia Pacific jurisdictions (Australia, Bangladesh, China, Hong Kong, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Vietnam, and New Zealand). Its core service suite covers independent license holding (where the manufacturer retains ownership of the registration certificate separate from local commercial partners), device registration and renewals, post-market vigilance, importing and customs clearance, and commercial support. The firm does not develop proprietary technology products; its value is delivered through in-country regulatory experts with an average of 21 years of medical device industry experience.

The company operates from an Americas headquarters in Austin, Texas, with an Asia regional headquarters in Singapore and wholly-owned operating subsidiaries in India, Indonesia, and the Philippines. Headcount is reported in the 11–50 range, and the firm has served over 300 companies from 38 client countries, supporting more than 2,000 registered products. The GTM motion is enterprise field sales to medical device manufacturers needing multi-country APAC clearance, and revenue is generated on a project/consulting-fee basis (professional services model); no public pricing exists. Marketing is driven by an extensive regulatory-updates blog and newsletter covering each APAC market.

The portfolio has expanded beyond core regulatory services into adjacent commercial offerings, including eCommerce platform services (enabling medical device sales on Lazada and Shopee in Southeast Asia), distributor oversight (channel evaluation and KOL engagement), and an in-house platform tool branded R.O.S.E. Ownership is founder-controlled (Bryan Gilburg, Managing Director), with no disclosed institutional funding, parent company, or M&A history.

Name

Asia Actual

Legal name

Asia Actual LLC

Website

https://asiaactual.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Asia Actual is a US-domiciled, Singapore-led professional services firm that serves as the local regulatory representative for medical device and IVD manufacturers across 16 Asia Pacific markets, providing registration, independent license holding, post-market vigilance, and customs clearance.

Ownership category

akta.pro rank

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices16 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Infrastructure, Others

Revenue model

1. Regulatory Consulting Services: Professional consulting fees for medical device registration, authorized representative services, independent license holding, post-market vigilance, importing and customs clearance support, and commercial support across Asia Pacific markets.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Asia Actual provides medical device registration, authorized representative, and independent license holding services across 16 Asia Pacific markets. The firm acts as the local regulatory representative for medical device and IVD manufacturers, handling registration submissions, post-market vigilance, importing and customs clearance, and commercial/distributor support.

Product overview

Asia Actual is a medical device regulatory consulting company offering a unified portfolio of regulatory and commercial services across 16 Asia Pacific markets. The core service suite consists of Independent License Holding, Device Registration, Post-Market Vigilance, Importing & Customs Clearance, and Commercial Support. These services are complemented by eCommerce platform services for online sales, Distributor Oversight for sales channel management, and the R.O.S.E. platform tool. The company serves as local regulatory representative providing authorized representative services and independent license holding across Australia, Bangladesh, China, Hong Kong, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, New Zealand, and Vietnam.

Differentiator

Problem solved

Functional benefit

Brands

• R.O.S.E. A platform/service offered by Asia Actual for market access solutions.

Products and services

• Independent License Holding Holds registration certificates on behalf of medical device manufacturers, keeping ownership separate from commercial partners to optimize sales channel management, IP protection, and regulatory support across APAC markets.
• Device Registration Direct engagement with local regulatory experts in each market to handle medical device and IVD registrations, maintenance, and renewals across Asia Pacific.
• Post-Market Vigilance Time-sensitive regulatory actions and post-market surveillance managed by experienced regulatory professionals in each market for medical device and IVD manufacturers.
• Importing & Customs Clearance Specialized importing and customs clearance support providing clarity into importing costs and processes to eliminate delays for medical device manufacturers moving products into APAC markets.
• Commercial Support Sales channel problem solving and commercial support delivered by seasoned local experts across Asia Pacific markets for medical device manufacturers.
• eCommerce Platform Services Comprehensive eCommerce sales program covering store establishment, translation, localization, customer management, inventory, and financial compliance for medical device sales on platforms like Lazada and Shopee in Southeast Asia.
• Distributor Oversight Sales channel management service including distributor evaluation, sales call participation, performance reports, coaching, training, and KOL identification in markets such as Malaysia.

Named customers6 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 indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Arriello: Arriello is a regulatory and quality consulting firm for medical devices, IVDs, and combination products, providing authorized representative and registration services across Europe and select global markets. It is directly comparable to Asia Actual as a similarly sized specialist firm offering outsourced regulatory affairs to medtech manufacturers seeking market access.
• ProPharma Group: ProPharma Group is a global regulatory, compliance, and clinical consulting firm serving pharma, biopharma, and medical device companies. It directly competes with Asia Actual in providing outsourced regulatory affairs, quality, and compliance services to medtech manufacturers, with overlapping authorized representative and registration capabilities.
• Pacific Bridge Medical: Pacific Bridge Medical is a consultancy that helps medical device, pharmaceutical, and IVD companies navigate regulatory and market access in Asia. It is a direct competitor to Asia Actual, offering similar registration, authorized representative, and distribution support services across Asian markets.
• PharmaLex (Cencora): PharmaLex, now part of Cencora (formerly AmerisourceBergen), is a global provider of regulatory, scientific, and compliance services for the pharma and medical device industries. It is a direct peer to Asia Actual in providing outsourced regulatory affairs and market access consulting, with comparable authorized representative services.
• IMed Consultancy: IMed Consultancy is a medical device regulatory affairs consultancy specializing in EU and international market access, offering authorized representative and CE marking services. It is a direct peer to Asia Actual as a similarly focused regulatory consulting firm for medtech manufacturers, though primarily EU-centric.
• RApport Global Strategic Services: RApport Global Strategic Services is a consultancy providing regulatory affairs, quality assurance, and clinical trial services to medical device and pharma companies. It is a direct peer to Asia Actual in providing outsourced regulatory and market access services to medtech manufacturers across international markets.

Broad incumbents

• IQVIA: IQVIA is a global CRO and life sciences services giant providing clinical, regulatory, and market access services. It is a broad incumbent competing for the same regulatory consulting and market access budget as Asia Actual, particularly with medtech manufacturers seeking multi-region coverage.
• ICON plc: ICON is a global CRO offering clinical research and regulatory services to pharma and medical device companies. It competes with Asia Actual at the broader regulatory and market access services layer, particularly for large medtech manufacturers with global rollout needs.
• Parexel: Parexel is a global CRO with regulatory consulting and market access offerings across pharma and medtech. It is a broad incumbent peer competing with Asia Actual for large multinational medical device manufacturers seeking full-service regulatory and clinical support.
• Deloitte (Life Sciences Regulatory): Deloitte's Life Sciences practice offers regulatory strategy, compliance, and market access consulting to pharma and medtech clients globally. It competes with Asia Actual at the higher end of the market, particularly for multinational manufacturers seeking Big-4 scale and integrated services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/asia-actual-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries4 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 Asia Actual