ARQon is a regulatory consultancy for medical devices and drug companies, in the aspects of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
Our team consists of individuals with different 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. Countries expertise:
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