ARQON PTE. LTD.

ARQon is a regulatory consultancy for medical devices, IVD's and drug companies. We assist our clients in aspects of regulatory and quality from development to product registration submission to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World. Our team consists of professionals with broad product category experiences in medical device and drug manufacturing sites, trading industry, ex-regulators from Singapore Health Sciences Authority and trainer for Asia and ASEAN regulators. Our range of clients includes researchers, manufacturers and traders from both start-ups and MNCs. Services offered: 1) Registration ASIA - Australia TGA/ARGMD, Bangladeshxa0DGDA, China NMPA, Hong Kong MDACS/MDCO, India CDSCO, Japan MHLW, New Zealand Medsafe, Pakistan DRA, South Korea MFDS, Taiwan FDA ASEAN - Cambodia DDF, Indonesia MOH, Malaysia MDA, Myanmar FDA, Philippines FDA, Singapore HSA, Thailand FDA, Vietnam AMERICAS - Brazil ANVISA, Canada Health, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA EUROPE – Notified Bodies MIDDLE EAST – Egypt CAPA, Saudi Arabia FDA, United Arab Emirates MOH 2) Development - Design History File (DHF), Technical File 3) QMS (Quality Management Systems) – US FDA QSR, GDPMD/S, MDSAP, ISO 13485 4) RMS (Regulatory Management System) 5) Warehouse storage and Distribution, Distributor Search, 3PL/4PL and toutlicensing/outsourcing 6) Post Clinical Evaluation of drugs and medical devices 7) Manufacturing Plant Set-up and Process Validation 8) Training management - Set up training system Tel: +65 69090396 Email: [email protected] twitter: @ARQonSG youtube: ARQon_Asia Regulatory & Quality Consultancy