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.
ASIA – Australia TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN – Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals AMERICAS – Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE – Notified Bodies Approval MIDDLE EAST – Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
2) Development - Design History File (DHF), Technical File
3) QMS – US FDA QSR, GDPMD/S, MDSAP, ISO 13485
4) RMS (Regulatory Management System) - SOP
5) Distributor Search and Distributing
6) Clinical Trial Plan and Conduct, Clinical Evaluation
7) Manufacturing Plant Set-up and Process Validation