ABOUT

Company

ARQon is a regulatory consultancy for medical devices and drug companies. We assist our clients in 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 range of clients includes researchers, manufacturers and traders from both start-ups and MNCs. Additionally, ARQon provides training sessions for researchers, manufacturers and regulators.

Vision      To be world-class regulatory service provider and to contribute to healthcare. 
Mission    To utilize our regulatory skills, expertise and connections to help our clients to resolve and comply with the regulatory requirements to meet
                 the quality, safety and effectiveness for medical device and drugs and obtain approval for healthcare use. We contribute to healthcare.

Team      

 

We are formed from individuals with vast experiences in medical device and drug manufacturing sites, trading industry and in regulatory authority.

  • With regulatory authorities background, we balance the nation's requirement for patients safety with the need to foster and advance medical options in an environment to limited resources,

  • We have experience in the manufacturing environment from start-ups to MNCs, from greenfield sites to mergers and acquisitons. We understand manufacturing targets, needs and limitations,

  • We have experience obtaining global registration from CE, US, Asia, ASEAN, and rest of the world (ROW). As a key partner to the sales and marketing function, we can pave the way to generate revenue and meet business targets,

  • We together share the same mission, we contribute to healthcare.

 

      ARQon Team     

Global Regulatory & Quality Director, ARQon group CEO

Bsc (Biochem & Microbio)

MSc (BioMedical Eng)

Grad Dipl (Medtech Manufacturing)

May

Biologics & Drugs

PhD in Microbiology

Stephen

Quality and Process

Validation

Engineering

Mike
Medical Device: Combination, Implants, IVDs
Global Product Registration, QMS, Audit 
ex: HSA, Biosensors
ASEAN-China & Singapore agencies advisors and committee, International speaker, 
Origin: Singapore, Malaysia, ASEAN
Biologics & Drugs
GMP, GLP, GDP, GDPMD
ex: HSA, GSK, Teva
Origin: US, Taiwan ROC, Singapore
Drug, Biologics, Medical device
Quality, Process Validation, Supplier audit, US QSR, GMP, IQ, OQ, PPQ
Origin: US, Singapore, Thailand

Regulatory & Quality Consultant

Bsc Mechanical Engineering

Ray
Global Product Registration, ISO13485,
FDA, QMS
ex: Oculus (MR), Illumina
Origin: Singapore

Regulatory & Quality Consultant

Bsc in Mechanical Engineering 

Sing Wee
Global Regulatory Strategy in Product Development, Technical Documentation (CE MDD/MDR), Design History File (US), GDPMD
Origin: Singapore, Malaysia
Trish Photo.png

Regulatory & Quality Consultant

Diploma in Biomedical Engineering

Trish
Global Product Registration
Origin: Singapore, Philippines 

Regulatory & Quality Consultant

ARQon Europe

Daniel
Product Development, Technical Documentation (CE), DHF (US), Clinical Evaluation, Combinations, Biocompatibility, EU MDD/MDR,
ex: TUV Rheinland auditor, US FDA 510k third party reviewer, Biosensors
DQS lead auditor for CE, ISO13485, MDSAP
Origin: Germany, Switzerland

Regulatory & Quality Consultant

ARQon Vietnam 

Henry
Product Registration, Product Development, Technical Documentation (CE), DHF (US), Active medical device, Chemical, EU MDD/MDR
Origin: Vietnam-IndoChina

Regulatory & Quality Consultant

ARQon Bulgaria

George
Product Development, Technical Documentation (CE), DHF (US), Active medical device, ChemicalEU MDD/MDR, Australia
ex: TUV SUD 
DEKRA lead auditor for CE, ISO13485
Origin: Australia, Europe
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Beatrice

Regulatory & Quality Consultant

Diploma in Biomedical Engineering

Global Product Registration
Origin: Singapore

Regulatory & Quality Consultant

Bsc Biomedical Science, GradCert MDRA

Siow Thing
ISO 13485, MDSAP, US QSR, Supplier Audit
Origin: Singapore

Regulatory & Quality Consultant

ARQon Europe

Judith
CE, Global news
TUV SUD academy trainer
Origin: Switzerland

Regulatory & Quality Consultant

ARQon Taiwan

Lyman
Clinical, Business, Registration
Clinician, Hospital & Pharmacy CEO
Origin: Taiwan

Regulatory & Quality Consultant

ARQon 

Titi
Distributor for MD, consultant for regulatory MD , License Holding, Calibration Certification of MD, Rent of MD and Home care & Medical evacuation
Origin: Indonesia

Regulatory & Quality Consultant

ARQon Thailand Representative 

Swairin
Sales & Marketing, Inventory Management, Pricing Management, Regulatory Affairs, Quality Assurance, Clinical Research and Reimbursement
Origin: Thailand

Sales

ARQon China

Lucia
Sales and Marketing
Origin: China

Sales

ARQon Brazil 

Diego
Sales and Marketing
Origin: Brazil

Regulatory

ARQon Israel 

Liat
Regulatory Affairs
Origin: Israel
Khalid

Sales

ARQon Bangladesh

Sales and Marketing
Origin: Bangladesh
Anas

Regulatory

ARQon Pakistan

Regulatory

ARQon Pakistan

Regulatory Affairs
Origin: Pakistan
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Kyser
Kyser

Regulatory

ARQon Singapore

Regulatory Affairs
Origin: Singapore

Sales

ARQon China

Eudora
Sales and Marketing
Origin: China

Regulatory & Quality Consultant

ARQon Hong Kong 

Albert
Expert in MD and IVD regulation, ISO13485/QSR, AHWP Pioneer, Professor of Practice (Biomedical Engineering)
ex: Ex-Medical Device Administration (MDA),
later established as Medical Device Control Office (MDCO)
Origin: Hong Kong
Marina

Sales

ARQon Russia 

Sales and Marketing
Origin: Russia
David

Asia/Global Business Development Director

ARQon Singapore

David

Asia/Global Business Development Director

ARQon Singapore

Distribution, marketing of medical device, orthopaedics, implant, physiotherapy device. 
Origin: Singapore
Talha

Regulatory

ARQon Pakistan

Regulatory Affairs
Origin: Pakistan
Azmina
Azmina

Regulatory

ARQon Malaysia

Regulatory Affairs
Origin: Malaysia
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Joel

Regulatory

ARQon Singapore

Joel
Regulatory Affairs
Origin: Singapore
Nadeem

Regulatory

ARQon Saudi Arabia

Regulatory Affairs
Origin: Saudi Arabia
C Y Won

Senior regulatory expert

ARQon Korea

Senior Regulatory Expert 
Origin: Korea
Ghalib

Regulatory

ARQon Pakistan

Regulatory Affairs
Origin: Pakistan
Ming Hui

IT Executive

ARQon Singapore