Additional Regulatory Services
Additional Regulatory Services
In addition to our core services, we offer a range of supplementary solutions to support every stage of your product’s lifecycle—from development and registration to post-market activities.
Our Advantages
Specialized IVD and Importation Services
We offer dedicated support for In Vitro Diagnostic (IVD) device registration and the regulatory aspects of product importation, ensuring full compliance at every stage.
Comprehensive Post-Market Surveillance
Our proactive monitoring and reporting services help you quickly address any emerging compliance issues, maintaining product safety and market reputation.
Global Market Expansion
Leveraging our regional expertise, we assist with registration and regulatory processes globally, paving the way for broader market access and growth.
How We Can Support?
As a licensed local authorized representative, we serve as the essential bridge between international manufacturers and Malaysian regulatory authorities.
IVD Medical Device Registration
Specializing in In Vitro Diagnostic (IVD) devices, we ensure that your diagnostic products comply with specific regulatory requirements tailored to testing and laboratory use.
Local Authorized Representative Services
Beyond consultancy, we serve as your long-term representative in Malaysia, managing ongoing regulatory interactions and compliance needs.
Importation Services
Our team assists with the regulatory aspects of importing medical devices and pharmaceuticals, ensuring that all products meet Malaysian standards upon entry.
Post-Market Surveillance
Once your product is on the market, we offer continuous monitoring and reporting services to ensure ongoing compliance and to swiftly address any issues that may arise.
Registration Service for ASEAN
With an understanding of the regulatory environments across ASEAN countries, we extend our expertise to support regional registration processes, ensuring your products can reach a broader market efficiently.
Cosmetics Registration
We simplify the process by providing end-to-end cosmetics registration services, including product notification with the National Pharmaceutical Regulatory Agency (NPRA), ingredient compliance checks, label review, and advisory on claims.
Phone: +60193878020