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 leverage our team's expertise in regulatory, commercial and connection to assist our clients in global market strategy, resolving issue, complying with the regulatory requirement and obtaining approval to meet the quality, safety and effectiveness for medical device, therapeutic and drugs usage. We aim to contribute our comprehensive services to Healthcare industry and MedTech community globally.
Team
We are formed from individuals with vast experiences in medical device and drug manufacturing sites, trading industry and in regulatory authority.
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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,
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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,
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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,
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We together share the same mission, we contribute to healthcare.
Global Regulatory & Quality Director, ARQon group CEO
Bsc (Biochem & Microbio)
MSc (BioMedical Eng)
Grad Dipl (Medtech Manufacturing)
May
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
ARQon Team
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Biologics & Drugs
GMP, GLP, GDP, GDPMD
ex: HSA, GSK, Teva
Origin: US, Taiwan ROC, Singapore
Global Product Registration, ISO13485,
FDA, QMS
ex: Oculus (MR), Illumina
Origin: Singapore
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Regulatory & Quality Consultant
Diploma in Biomedical Engineering
Trish
Global Product Registration
Origin: Singapore, Philippines
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Regulatory & Quality Consultant
Diploma in Biomedical Engineering
Beatrice
Global Product Registration
Origin: Singapore
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Regulatory Affairs
Origin: Singapore
Senior Corporate Administrator
ARQon Singapore
Bing Kang
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HR Affairs
Origin: Singapore
Our Clients
What Our Clients Say
“ARQon has help AWAK achieve zero non-conformity during our ISO 13485: 2016 Quality Management Audit is not an easy feat to achieve. We like to thank them for their dedication and commitment in their work.”
“ARQon has help to complete the MDSAP gap analysis in a timely and professional manner and as a result we have reached a new milestone in achieving MDSAP certification effortlessly for MediPurpose.”
