RABT Global is a specialist in comprehensive regulatory affairs solutions for medical devices and pharmaceuticals, supporting global and APAC market access through expert consulting, registration, and compliance services.
RABT Global’s offerings include:
End-to-End Regulatory Consulting: Tailored strategies for regulatory submissions, registration, and lifecycle management to ensure compliance with APAC health authorities and global standards.
Quality Management System (QMS) Services: Guidance and auditing aligned with ISO 13485 and country-specific requirements, enabling robust quality frameworks and readiness for market access.
Documentation and Submission Support: Preparation and review of technical files, dossiers, translations, and communication with regulatory agencies (such as China NMPA, Japan PMDA, India CDSCO, Australia TGA, Singapore HSA).
Local Representation: Acting as in-country authorized representatives where needed, facilitating smooth regulatory interactions.
Post-Market Surveillance: Vigilance, adverse event reporting, and ongoing compliance monitoring for continuous market success.
Global Reach: RABT supports clients from startups to large corporations, expediting approvals and reducing operational costs while ensuring timely, compliant product launches in APAC and worldwide
APAC Country Coverage
We deliver regulatory support for medical devices in:
Greater China (Mainland China, Hong Kong, Taiwan)
Japan & South Korea
Australia & New Zealand
India
Southeast Asia (Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines)
Other APAC Members as needed
RABT Global differentiates itself by leveraging industry-leading expertise and a proactive, client-focused approach—enabling life science innovators to navigate complex regulations and achieve rapid market adoption, including in rapidly evolving APAC regulatory environments.
Partnering with RABT Global ensures your medical devices go beyond local compliance—achieving rigorous certification, swift market entry, and sustainable success in Asia-Pacific and global markets
