Regulatory & Services

With our combined experience of more than 30 years in clinical research, regulatory affairs and quality management system, we understand the importance of cost and time as well as the technical quality of the result, and compliance with regulatory requirements.

Our Services

Medical devices registration

Our team are able to provide services to assist in the product registration of medical devices with regulatory authorities in Malaysia and Singapore, ensuring compliance with local regulations. We are also an Authorized Representative for Malaysia MDA and Singapore HSA

Clinical research and management

Our team has a broad background in clinical study management for phase II/III/IV trials, registries, and a variety of therapeutic areas. We offer one-stop services for protocol development and clinical study documentation, ensuring seamless support for your clinical research needs.

Co-sourcing for regulatory service

We collaborate with external service providers to fulfil your specific regulatory or QA needs, so we can efficiently manage regulatory and QA processes, improve compliance, and reduce costs, helping you to meet your business goals.