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.
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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.
ARQon Team
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
Global Product Registration, ISO13485,
FDA, QMS
ex: Oculus (MR), Illumina
Origin: Singapore
Global Regulatory Strategy in Product Development, Technical Documentation (CE MDD/MDR), Design History File (US), GDPMD
Origin: Singapore, Malaysia
Global Product Registration
Origin: Singapore, Philippines
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
Product Registration, Product Development, Technical Documentation (CE), DHF (US), Active medical device, Chemical, EU MDD/MDR
Origin: Vietnam-IndoChina
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
Global Product Registration
Origin: Singapore
ISO 13485, MDSAP, US QSR, Supplier Audit
Origin: Singapore
CE, Global news
TUV SUD academy trainer
Origin: Switzerland
Clinical, Business, Registration
Clinician, Hospital & Pharmacy CEO
Origin: Taiwan
Distributor for MD, consultant for regulatory MD , License Holding, Calibration Certification of MD, Rent of MD and Home care & Medical evacuation
Origin: Indonesia
Sales & Marketing, Inventory Management, Pricing Management, Regulatory Affairs, Quality Assurance, Clinical Research and Reimbursement
Origin: Thailand
Sales and Marketing
Origin: China
Sales and Marketing
Origin: Brazil
Regulatory Affairs
Origin: Israel
Sales and Marketing
Origin: Bangladesh
Regulatory Affairs
Origin: Pakistan
Regulatory Affairs
Origin: Singapore
Sales and Marketing
Origin: China
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
Sales and Marketing
Origin: Russia
Distribution, marketing of medical device, orthopaedics, implant, physiotherapy device.
Origin: Singapore
Regulatory Affairs
Origin: Pakistan
Regulatory Affairs
Origin: Malaysia
Regulatory Affairs
Origin: Singapore
Regulatory Affairs
Origin: Saudi Arabia
Senior Regulatory Expert
Origin: Korea
Regulatory Affairs
Origin: Pakistan
IT Executive
Origin: Singapore
HR Affairs
Origin: Singapore
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.”
Expertise Categories - We have subject matter team handles product technical testing and questions from authorities.
Technical - Biocompatibility, Sterilization, Stability, Electrical, Mechanical, Software validation
Product - Medical device, Drug, Biologics, Cosmetic, Health Supplement, Irradiated device
Documentation - Design History File, Technical File, STED, CSDT, Country-Specific Dossier
Quality & Compliance - GDPMD/GDPMDS, ISO 13485, MDSAP, US QSR, GMP, GLP, Validation, Process
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