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Handling regulatory compliance in-house could be costly and burdensome, especially where resources are scarce or already stretched. Our services are tailored to meet the needs of medical device and pharmaceutical companies and we can help speed up your compliance process with our knowledge and expertise. Browse our services below to see how we can offer you a cost-effective solution to quality management systems, product registrations or authorised representation.
A quality management system (QMS) for compliance with regulatory requirements for healthcare products is a formalised and structured system of processes and procedures constructed to cover aspects such as design, production, supplier management, risk management, storage, distribution, product labelling, complaints handling and adverse incidents.
We can register your medical devices with the Malaysian Medical Device Authority (MDA); cosmetics, health supplements and pharmaceuticals with the National Pharmaceutical Regulatory Agency (NPRA); have your products CE marked so you can market them freely in the European Union. Need to file a change notification? We can do that too.
All foreign manufacturers of medical devices must have a local Malaysian entity representing them. By appointing Cubic Life Sciences as your local authorised representative (LAR), you will have an independent party managing your registrations and holding the product licences on your behalf; we do not import or distribute products, we only undertake regulatory work. This service enables you, the manufacturer, to appoint and change importers and distributors without the issue and cost of changing labels and transferring licences.
We are a premium quality solutions provider. With a highly knowledgeable and experienced team, we can guide you through the intricacies of regulatory compliance.