ATTOPOLIS@ARQon-Asia Regulatory & Quality Consultancy (MedTech & Drug)

ARQon International Business Group, operating through its ATTOPOLIS platform, specializes in regulatory affairs and quality assurance consulting for medical technology and pharmaceutical companies seeking market access across Asia-Pacific. Led by founder May Ng, who spent 10 years at Singapore's Health Sciences Authority (HSA) and served as MEDICS lead approving over 1,400 devices, the company combines regulatory authority experience with industry expertise.

The firm provides medical device and drug registration services across 13 countries including Singapore, Malaysia, Taiwan, Vietnam, Indonesia, Philippines, Thailand, South Korea, Hong Kong, China, India, and Rwanda. Core services include product registration, in-country license holding, ISO 13485/GDP quality management system implementation, technical file preparation, clinical evaluation reports, and supplier audits. ARQon has worked with major medical technology companies including Sysmex, Varian, Omron, Invisalign, and Zeiss.

Beyond regulatory services, ARQon operates several complementary platforms: ATTOPOLIS (B2B marketplace for healthcare products), International Medical Device School (training for MedTech professionals), ATTOMATCHING (connecting startups with investors and partners), and QuikQuality (eQMS/eRMS dashboard). The company maintains physical offices in Singapore, Malaysia, Taiwan, Vietnam, and Rwanda.

Companies should consider ARQon when they need insider regulatory knowledge for Asia-Pacific market entry, particularly when founder May Ng's HSA experience and local regulatory relationships provide strategic advantage. The firm's in-country license holding services address a critical need for companies without local entities.

Expect a consultancy model that extends beyond pure regulatory submission to encompass quality system implementation, business development support, and ongoing regulatory maintenance. The integrated platform approach may benefit companies seeking comprehensive market access support including distributor connections and investor introductions through ATTOMATCHING.

ARQon operates exclusively within the healthcare sector, focusing on regulatory compliance for medical devices (Class I-III), in vitro diagnostics, pharmaceuticals, cosmetics, dietary supplements, and medical device packaging. The company's healthcare specialization is demonstrated through ISO 13485 certification services, clinical evaluation report preparation, and technical file development specific to medical technology regulatory frameworks.

The firm maintains deep expertise in healthcare-specific compliance requirements including GDP (Good Distribution Practice) for medical device supply chains, HSA MEDICS system navigation, and ASEAN medical device regulatory harmonization. Healthcare vertical experience spans diagnostic equipment, radiation devices, drug-eluting stents, orthodontic devices, and digital health applications.

Medical device and IVD manufacturers seeking to expand commercial operations across multiple Asia-Pacific markets who need regulatory strategy development, submission management, and in-country representation. Companies requiring ISO 13485 quality system implementation or GDP compliance for distribution operations. Healthcare technology startups needing guidance on regulatory pathways and potential investors or distribution partners in Asian markets.