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Global RA Consultancy Network

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

All consultants in our network are reviewed and verified — ensuring you connect with qualified, reliable industry experts.

Showing 7 of 7 consultancies

Registrar Corp

Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa

Registration

A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.

Specializations

FDA Registration & Renewal
U.S. Agent Services
Labeling & Ingredient Review
MoCRA Compliance (Cosmetics)
Food Safety (FSMA/PCQI)
Detention Assistance
Medical Device Listing (510k assistance)
Drug Establishment Registration
Adverse Event Management

Languages: English, Chinese (Mandarin & Cantonese), Spanish, French, German, Italian, Japanese, Korean, Portuguese, Russian, Hindi, Arabic, Thai, Vietnamese, Indonesian

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MedEnvoy Global

The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia

Registration

A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.

Specializations

EU Authorized Representative (EC REP)
UK Responsible Person (UKRP)
Swiss Authorized Representative (CH REP)
US Agent
Independent Regulatory Importer (EU, UK, CH)
Regulatory Consulting
EUDAMED Registration

Languages: English, Dutch, German, French

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CMIC Holdings Co., Ltd.

Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia

Registration
Marketing

We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.

Specializations

Clinical Research Organization (CRO) Services
Contract Development and Manufacturing Organization (CDMO/CMO)
Site Management Organization (SMO)
Regulatory Affairs & Strategy
Post-Marketing Surveillance (PMS)
Data Management & Biostatistics
Medical Device Regulatory Support
Drug Development Outsourcing (Phase I-IV)

Languages: Japanese, English, Chinese (Mandarin), Korean

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IMed Consultancy Ltd

United Kingdom, Ireland

Registration

Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.

Specializations

Medical Devices
In-Vitro Diagnostics (IVD)
Global Registration
UK Responsible Person
Quality Management System
Training
Resources

Languages: English

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Regulatory Insight, Inc.

Nashville, USA

Registration

We are a consultancy specializing in FDA medical device compliance, submissions, training, and export/import services.

Specializations

FDA 510(k) Premarket Notification
FDA PMA Premarket Approval Application
FDA De Novo Reclassification Request
FDA and ISO 13485 Compliant Quality Systems
Medical Device Single Audit Program (MDSAP) Preparation
FDA 483 Warning Letter Response and Remediation
FDA Establishment Registration and Device Listing
U.S. Agent Representation for Medical Devices
Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID)
Health Canada Medical Device License (MDL) and Medical Device Establishment License (MDEL)
European Medical Device Regulation (MDR) CE mark
Australian TGA Registration for Medical Devices
Employee Regulatory and Quality Systems Training for Medical Devices
Assistance with Medical Device Import and Export Issues

Languages: English

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meditec Consulting GmbH

Boll, Switzerland

Registration

We provide consulting services to the medical device, pharmaceutical and healthcare industry. Our services include Regulatory Affairs, Quality Management, Risk Management, Trainings and Seminars.

Specializations

RA strategy
medical device and IVD regulations
preparation and submission of technical documentation for EU, USA, Canada and other markets
Quality system compliance in accordance with ISO 13485, CMDCAS and FDA QSR
FDA inspections
Notified body audits
Device Vigilance reporting
Risk- and usability management
Packaging Validation
Submission management for pharmaceuticals
EU/CH Pharmacovigilance
Regulatory Intelligence
eCTD Dossier Publishing
Variations in CH
Project Management
strategy and carrying out of documentation
technical files in development projects
training
change management and CAPA

Languages: English, German, French

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Emergo by UL

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

Registration

A dedicated partner for medical device and IVD manufacturers, we 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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