Brand profile · Business Consulting

ATTOPOLIS@ARQon-Asia Regulatory & Quality Consultancy (MedTech & Drug)

ATTOPOLIS@ARQon-Asia Regulatory & works in Business Consulting, out of Singapore. Ownership is privately held; it publishes at arqon.com. The record carries four addresses across four office countries. The record counts 27 people. Tagged QMS (ISO 13485, GDPMD/S and 21 CFR part 820 and MDSAP). The record links six similar brands, most of them in Medical Device.

arqon.com LinkedIn

Profile live Privately Held Founded 2014 4 office countries
Counted staff
27
self-reported 11–50 band
Founded
2014
12 years
Legal entities
None matched
Office countries
4
4 addresses
Funding rounds
None on record
Company type
Privately Held
self-reported
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Description

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, Bangladesh DGDA, 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 outlicensing/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: info@arqon.com

twitter: @ARQonSG youtube: ARQon_Asia Regulatory & Quality Consultancy

Specialties

All 8 specialties
  • QMS (ISO 13485
  • GDPMD/S
  • 21 CFR part 820 and MDSAP)
  • Medical Device Regulatory Affairs
  • Pharmaceutical Regulatory Affairs
  • Distributor Search
  • Medical Device Registration
  • Drug Registration

Locations

4
Countries with an office address4 addresses on record
SingaporeprimaryMalaysiaSwitzerlandTaiwan

Country footprint

Offices in 4 countriesCountry footprint: 4 countries, primary SG. Codes: SG, CH, MY, TW.4 countriesprimary SGSGCHMYTW
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Countries4
Primary countrySG

All codes: SG CH MY TW

Addresses

  • CHBundesgasse 26; Bern, 3011
  • SG2985 Jalan Bukit Merah, #01-1C Education Wing, Singapore Manufacturing Federation; Singapore, Singapore 159457Primary
  • MY20-3, Jalan 8/23E, Taman Danau Kota; Kuala Lumpur, Kuala Lumpur 53300
  • TWNo.16 Minsheng Street; Sanchong District; New Taipei City, Taipei 241

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People & contacts

4 employee profiles on record · names withheld.

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FAQ

How many people work at this brand?

The record holds 27 counted staff profiles at January 2026, inside the self-reported 11–50 band.

Where does this brand have offices?

Four addresses on record across 4 countries. Primary: 2985 Jalan Bukit Merah, #01-1C Education Wing, Singapore Manufacturing Federation, Singapore 159457.

Has this brand raised funding?

None linked to this brand.

What does this brand list as its specialties?

Eight tags on the brand's own list, among them QMS (ISO 13485, GDPMD/S and 21 CFR part 820 and MDSAP).

Which companies are listed alongside this brand?

8 profiles list ATTOPOLIS@ARQon-Asia Regulatory & Quality Consultancy (MedTech & Drug) as a peer — 93rd percentile in Business Consulting. It lists ten peers of its own. Andaman Medical and MedtechBOSS list it back.

What is this brand's website?

arqon.com