Regulatory affairs and market access for medical devices & IVDs across Southeast Asia since 2013
Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape and bring your products to market efficiently and compliantly.
Key Leadership & Expertise
As Group President, Mourad steers the company’s strategic direction, fostering a unified approach across all regions. With years of industry experience, Mourad provides strong leadership, ensuring each team is equipped to meet client needs effectively
Paul oversees operational efficiency across all regions, ensuring teams perform at their highest potential. With expertise in operational management, he ensures seamless execution of every project, from product registration to market launch.
May spearheads our global marketing strategy, ensuring each region’s distinct value proposition is communicated clearly. Her expertise ensures a cohesive brand presence while customising messages to resonate with local markets.
Nuradhilla ensures compliance with local and international regulations across all regions. By guiding teams through complex legal frameworks, she minimises risks and ensures seamless regulatory adherence across borders.
Leading our business development and client relationship efforts, ShouZheng brings extensive experience in medical device market trends across Southeast Asia. Their insights enable teams to stay focused on client needs and regional market demands.
Melody oversees logistics, ensuring efficient execution of services from market entry to compliance. With a strong grasp of local customs and regulations, she ensures timely deliveries and strict regulatory adherence.
As Group President, Mourad steers the company’s strategic direction, fostering a unified approach across all regions. With years of industry experience, Mourad provides strong leadership, ensuring each team is equipped to meet client needs effectively
Nach leads our global human resources strategy, fostering a people-centric culture that aligns with our business goals. Her expertise ensures talent development, organizational growth, and a workplace where employees thrive.
Nuradhilla ensures compliance with local and international regulations across all regions. By guiding teams through complex legal frameworks, she minimises risks and ensures seamless regulatory adherence across borders.
Leading our business development and client relationship efforts, ShouZheng brings extensive experience in medical device market trends across Southeast Asia. Their insights enable teams to stay focused on client needs and regional market demands.
Melody oversees logistics, ensuring efficient execution of services from market entry to compliance. With a strong grasp of local customs and regulations, she ensures timely deliveries and strict regulatory adherence.
Our Teams in Southeast Asia
We offer tailored solutions for each market, ensuring that our clients benefit from local experience while adhering to international best practices.
Indonesia
Indonesia
Specialising in product registration, post-market surveillance, and local compliance in Bahasa Indonesia, our local team is able to offer seamless market access minus the fuss. Our team has years of experience and deep understanding of Indonesia’s unique regulatory environment, which helps expedite the approval process and ensure that all regulatory requirements are met accurately and efficiently.
Malaysia
Malaysia
Our Malaysia team consists of regulatory and distribution experts, offering compliance solutions in both Bahasa Malaysia and English. With a proven history of successful product registrations and market launches, they bring deep insights into the local healthcare ecosystem. From consultation to approval, they provide comprehensive support through every stage of the regulatory process.
Vietnam
Vietnam
Our Vietnam team brings extensive expertise in the medical device sector, offering key insights into regulatory changes, product registration, and compliance monitoring. Fluent in Vietnamese, they ensure your business stays competitive and fully compliant in this fast-evolving market.
Thailand
Thailand
Navigating Thailand’s complex regulatory landscape, our Thailand team, fluent in Thai, offers expert guidance from product registration to regulatory updates. With deep knowledge of local laws, they ensure seamless operations and compliance.
Philippines
Philippines
Our Philippines team specialises in navigating local regulatory frameworks, providing expertise in product licensing, adverse event reporting, and post-market surveillance. Fluent in Filipino and English, their local presence and industry expertise ensure compliance at every stage.
Singapore
Singapore
Our Singapore team is at the forefront of product registration, post-market surveillance, and navigating customs regulations. With proficiency in English and Mandarin, and expertise in ISO 13485 standards, they provide comprehensive support to help clients succeed in a fast-changing regulatory landscape.
Cambodia
Cambodia
As Cambodia’s regulatory landscape evolves, our Cambodia team provides strategic insights and proactive guidance for market entry and compliance. Fluent in Khmer, with a deep understanding of the local market, they help ensure your business thrives in this emerging region.
Our Values
Responsibility
Take ownership, however it’s ok to make mistakes!
Integrity
Act honestly and have strong moral principles
Collaboration
Work together and support group/organisational objectives
Energy
Bring a level of enthusiasm and willingness to your work
