Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise. We don’t outsource unlike other consulting firms who do not have in-house staff and must contract external consultants on an ad-hoc project basis. This means our clients are reassured that they can safely rely on our dedicated team of employees over the long-term and throughout the region. Acting as the in-country representative, we prepare, submit and manage device registrations for our clients giving them independence and flexibility over their market access and distribution strategy. And unlike software platforms that simply act as documentary repositories for online registrations, we provide our clients with the ongoing insight on how to navigate the complex regulatory arena particularly at this time of increased post-market surveillance (PMS) and constantly updated compliance requirements. Leveraging our local expertise and presence, our clients can access markets with even greater ease thanks to our importation and master distribution services. We ensure medical devices obtain customs clearance and are distributed to the end customer, leaving clients to concentrate on their business. Founded in 2013, we decided to focus exclusively on Southeast Asia and have grown over the last seven years to open six ASEAN offices in Singapore, Malaysia, Indonesia, Philippines, Vietnam and Thailand. We register, represent and import 1000+ medical devices & IVDs of all classes and all therapeutic areas from ophthalmics to orthopaedics, from cardiovascular to CNS, from diabetes to diagnostics and much, much more.
