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ARQon's Services
ARQon International Business Group specializes in Regulatory consultancy, Commercial advisory and services, Training and Digital platform to support companies to gain global market access.
Our team combines industry and ex-regulatory experiences, local networks and relationships to navigate your regulatory and market objectives to develop a solid strategy for your market access as we understand regulatory fast track and requirements for your product type. We present globally to serve your different needs.
Regulatory Approval
Business Ventures
B2B2C Global Ecosystems
Training & Incubator
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Product registration (medical device, drug, cosmetic, supplements, packaging and safety)
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In-Country License Holding
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Tapping Manufacturer ISO & Distributor GDP
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QMS ISO13485/GDP/QSR/CE set up/Supplier Audit
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Regulatory Strategy, Technical File, Clinical and CER
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QuikQuality RAQA Dashboard
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Monthly support RA/QA/Admin
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Business setup
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Matching (Distributor, CDMO, Investor, Clinician, Partner)
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Overseas business development (Outlet, Online Shop, Booth)
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Market strategy & branding
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Omnichannel Social Media Marketing management
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Experts Legal, IP, Investment, Compliance, Corporate services
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Product & Service Marketplace
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One Stop Business Solution
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Showcase Innovations & Consumer Care
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Country Pavilion with Embassy/Association
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Networking, Event, Forum
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Outreach Partner Program
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Training for MedTech Professionals (design, manufacturing to commercialization)
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Incubator for Entrepreneurs
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Alliance for Healthcare Startup in Asia
ARQon Management Team
May Ng
Group CEO
• Founder of ARQon Group, MedTechBOSS, IMDS, ATTOPOLIS B2B (8 years)
• Product Manager for IVDs, Poison & Radiation device (2 years)
• Singapore Health Science Authority (HSA) regulation implementation & MEDICS lead, approved 1400 devices & dealers, key author guidances CSDT & GDPMDS (10 years)
• Biosensors, Regulatory Director drug eluting stent in Manufacturing Site for Global approval, Technical Fille & audit (4 years)
• Advisor for SG (NHIC, ASTAR, IPI), Korea (KHIDI), Ministry of Law’s COVID Assessor, US-ASEAN Regulatory Group, International Speaker (Medica Asia, MEDICA Düsseldorf, Medtech Summit Europe)
• Past: ASEANMed Co-chair, Singapore Manufacturing Federation Council, Medtech Industry Capability Development & Youth chair, US-China ASEAN Medical Cooperation Committee, AHWP, ASEAN MDPWG, Trainer for Regulators, Prime Minister Office’s Tech Assessor
MANAGEMENT DIVISIONS
Stephen Hsu
Quality & Tech Director
QUALITY & TECH
Ray Soh
Global Regulatory Director
REGULATORY, Device
Dr Wong Tee Wee
Global Regulatory Director
REGULATORY, Drugs
Al Low
International Venture Services Director
COMMERCIAL, Global
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Danny Koh
Supply Chain Deputy Director
BUSINESS & INVESTMENT
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Sean Ng
Operations Manager/ Deputy Director
CORPORATE AFFAIRS
Deepak Jamle
Business Marketing Deputy Director
MEDTECHCOM
Ericz Tay
Knowledge Partner
LEGAL
FUNCTIONAL OFFICES
Bing Kang
Senior Administrator
OPERATION
Afif
Regulatory & Quality Associate
REGULATORY & QUALITY
Ann
Business Analyst
BUSINESS & FINANCE
Dino
Regulatory & Quality Associate
REGULATORY & QUALITY
Kah Suan
Project Coordinator
PROJECT MANAGER
Insyirah
PA to CEO
SECRETARIAT
Kai Li
Regulatory Affairs Associate
REGULATORY & QUALITY
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Our Clients
Regulatory
• Product registration & Product License Holder for implant, IVD, AI & therapeutics, (eg drug, supplement)
• Monthly regulatory support for regional registration
• Wireless, radiation & mandatory packaging reporting to Authority
• Post-market reporting to Authority on adverse event & recall
B2B Marketplace,
Forum, News
• Product listing by manufacturer
• Post forum used by startups to request for distributor search
• Service providers (eg contract manufacturer & translation) to list their service
• Distributors to look for innovation product
• Organizations to post event, HSA focus group & public consultation, funding to share to medtech professionals.
Commercial
• Connect to Clinician, advise on new indications & training. Connect 3PL or Tapping MedtechBOSS Importer/Wholesaler/Product owner GDPMD/ISO for supply to hospitals
• Country Trade mission business matching for EU companies to SG potential partners (1-5 per company)
• Find & Set up Importer, Distributor, Rep License with MOH, advise staff hiring & space compliance requirements (eg Indonesia)
• Provide clinical funding, regulatory & commercial support (eg tech licensee, investor to the start-up for working with all 6 clusters of SG hospitals Innovation centre)
Quality
• ISO 13485, MDSAP, USQSR, MDR, IVDR QMS setup, supplier, internal/mock audit, maintain when staff leaves/left
• MDD, IVDD transition to MDR, IVR with gap analysis, compliance work
• GMP Biologics advisory for HSA certification audit, Process validation advisory
• Global Regulatory Strategy, Classification and Borderline Drug/Device/Lifestyle/Cosmetic assessment
Technical
• Provide template, guide & check technical documents to build Design History File, Medical Device File
• Training to industry & regulator on ISO 13485, Design Control, Asia Registration, MDSAP, Global regulatory strategy, ASEAN CSDT & review requirements for approval
• Biocompatibility assessment requirements, Clinical Evaluation Plan & Report
