David Lee's Contact Details

David Lee's Company Details

ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs

Singapore, , Singapore • 1 - 10 Employees
Medical Devices

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) RegistrationASIA – Australia TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO ApprovalsASEAN – Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC ApprovalsAMERICAS – Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA ApprovalsEUROPE – Notified Bodies ApprovalMIDDLE EAST – Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals2) Development - Design History File (DHF), Technical File3) QMS – US FDA QSR, GDPMD/S, MDSAP, ISO 134854) RMS (Regulatory Management System) - SOP5) Distributor Search and Distributing6) Clinical Trial Plan and Conduct, Clinical Evaluation7) Manufacturing Plant Set-up and Process Validation8) TrainingTel: +65 69090396Email: info@arqon.comtwitter: @ARQonSGyoutube: ARQon_Asia Regulatory & Quality Consultancy