Global RA Consultancy Network

Connect with our trusted network of regulatory affairs consultancies specializing in medical device registration and compliance across major global markets.

Disclaimer

The information provided about consultancies is for reference purposes only. ElendiLabs does not guarantee the accuracy, completeness, or currency of the information. Users are advised to verify all details directly with the respective consultancy before engaging their services. ElendiLabs is not responsible for the services, advice, or actions of any listed consultancy.

Showing 5 consultancies

Pacific Bridge Medical

USA, China, Japan, Singapore, Hong Kong, India (Affiliate), Indonesia (Affiliate), Korea (Affiliate), Malaysia (Affiliate), Philippines (Affiliate), Taiwan (Affiliate), Thailand (Affiliate), Vietnam (Affiliate)

A boutique consulting firm specializing in Asian medical and pharmaceutical regulatory affairs and business development. We provide comprehensive, on-the-ground support for market entry, registration, quality compliance, and local agent representation across 12 Asian markets.

Specializations

Regulatory Strategy

Product Registration

Market Access/Reimbursement/Health Economics

Quality Compliance

Local Agent Representation

Clinical Trials

Business Strategy

Distributor Search

Sourcing & Manufacturing

Acquisitions, Joint Ventures, & Licensing

Recruiting

Languages: English, Japanese, Chinese (Mandarin & Cantonese), Korean, Thai, Vietnamese, Bahasa Indonesia, Bahasa Malaysia

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Emergo by UL

USA, Canada, Brazil, Australia, China, Hong Kong, Taiwan, India

A dedicated partner for medical device and IVD manufacturers, Emergo by UL offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.

Specializations

Languages: English, Chinese (Mandarin & Cantonese), Japanese, Korean, Spanish, Portuguese, German, French

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Qualtech Consulting Corporation

Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA

A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. Qualtech offers real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.

Specializations

Regulatory Consulting (Product Registration)

Clinical Trials (CRO)

Local Authorized Representation

Post-Market Activity

Quality Management Systems (QMS)

Clinical Evaluation Report (CER)

Market Access Strategy

Languages: English, Japanese, Chinese (Mandarin & Cantonese), Korean, Thai, Vietnamese, Bahasa Indonesia, Bahasa Malaysia, German

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Cisema (Hong Kong) Limited

Beijing, Hong Kong, Singapore, Tokyo, Seoul, Munich, Vienna, Chicago, Covetry, Hangzhou, Qingdao, Tianjin, Malaysia, Indonesia, Vietnam, Taiwan

Leading provider of regulatory affairs and quality compliance across Asia Pacific with 20+ years of China experience. Comprehensive services from market entry strategy to factory inspections.

Specializations

NMPA Medical Device Registration

NMPA IVD Registration

Clinical Trial Services

Legal Agent Services

Hong Kong MDACS Registration

Taiwan FDA Registration

Malaysia MDA Registration

Singapore HSA Registration

Vietnam MoH Registration

Indonesia MOH Registration

Philippines FDA Registration

Thailand MoPH Registration

Quality Management & GMP

Pharmaceutical Registration

Cosmetics Registration

Languages: English, Chinese (Mandarin & Cantonese), German, Italian, French, Japanese, Korean

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ElendiLabs

Hong Kong

ElendiLabs specializes in medical device regulatory affairs in Hong Kong, providing comprehensive support for MDACS registration and compliance.

Specializations

MDACS Registration

Medical Device Classification

Regulatory Strategy & Planning

Compliance Consulting

Post-Market Surveillance

Local Responsible Person (LRP) Services

Dossier Preparation

Clinical Evaluation Support

Languages: English, Chinese (Cantonese), Chinese (Mandarin)

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