Regulatory Representation Services | Global Regulatory Liaison & Agency Services
Specialist regulatory representation services for pharmaceutical and medical device companies — delivered by RABT Global’s expert regulatory team.
Regulatory representation services are a statutory requirement in many markets — and a strategic asset in all of them. Whether you need an EU Authorized Representative under EU MDR, a US FDA Agent under 21 CFR 807.40, or a local regulatory representative services arrangement in markets where in-country representation is required, RABT Global provides the full spectrum of global regulatory representative services. Our regulatory liaison services ensure that your products remain visible, compliant, and commercially accessible in every market — without the cost and complexity of building local regulatory infrastructure.
Initial Consultation & Needs Assessment
We review your specific regulatory representation services requirements, target markets, and timelines to scope the engagement.
Strategy & Planning
Our specialist team develops a tailored approach aligned with applicable regulatory requirements and your commercial objectives.
Delivery & Execution
We execute the defined scope — producing regulatory-compliant deliverables to the highest quality standards.
Review & Quality Assurance
All deliverables undergo independent review and quality check before client delivery.
Ongoing Support
RABT Global remains available for follow-up queries, regulatory authority interactions, and lifecycle support.
Our Regulatory Representation Services
EU Authorized Representative (EU AR)
statutory EU MDR/IVDR authorised representative for non-EU manufacturers
US FDA Agent Services
tatutory US Agent for foreign device and pharmaceutical establishments
Regulatory Communication Support
management of health authority correspondence across global markets
Local Regulatory Representative Services
in-country representation in GCC, India, and emerging markets
Health Authority Representation
representation at regulatory meetings, inspections, and scientific advisory interactions
Regulatory Compliance Representation
ongoing compliance monitoring and regulatory status management
Regulatory Sponsor Representation
acting as regulatory sponsor for clinical trial applications in applicable markets
Regulatory Point of Contact Services
serving as the named regulatory contact for multi-market registration programmes
Regulatory Representation Services — FAQs
A: A regulatory representative (or regulatory agent) is a person or organisation appointed to act on behalf of a manufacturer or marketing authorisation holder in dealings with health authorities in a specific market. Regulatory representation services are required by law in many markets (EU MDR, FDA) and by practice in others where local representation facilitates more effective regulatory management. RABT Global provides global regulatory representative services across all major markets.
A: Not always — but in many key markets, regulatory representation is a statutory obligation. Non-EU manufacturers must appoint an EU Authorized Representative for EU MDR/IVDR CE-marked devices. Foreign establishments importing to the US must appoint a US FDA Agent. Many Middle Eastern countries require a local regulatory agent or sponsor for product registration. RABT Global’s regulatory representation services cover all mandatory and advisory representation requirements.
A: RABT Global combines specialist regulatory representation services expertise with a proven track record across 200+ global clients. Our regulatory team brings multi-jurisdictional knowledge, integrated regulatory and medical writing capabilities, and a genuine partnership approach — making us the regulatory representation services provider of choice for pharmaceutical and medical device companies worldwide.
Expert Regulatory Representation Services — Partner with RABT Global
Get specialist regulatory representation services from RABT Global’s expert regulatory team. Trusted by 200+ life sciences companies worldwide.