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Lifesciences Regulatory Compliance Services in Singapore
Our priority is the same as yours – patient safety. Artixio presents you with regulatory, testing, market entry and post market entry services for all life science industries. Collaborate with us for streamlined market entry, Health Sciences Authority (HSA) regulatory compliance and solutions, and ongoing support services.
Singapore
Regulatory Authority in Singapore
Health Sciences Authority (HSA) is responsible for the regulation of all health products including medicines, medical devices and blood supply for its safety, efficacy and quality which influences public health. They oversee the manufacturing, importing, exporting and supply of health products within Singapore. With increase in the unmet medical needs, more development of drugs and products are being conducted day by day.
In relation to the expedition of market availability of the drug, HSA has encountered many substandard, damaged or products that might not perform its function in the long run. To overcome this hurdle, HSA has decided and set forth rules and regulations to comply with for pre and post product registration and market approval for every product being marketed in Singapore.
Regulatory Consulting for Singapore Market Access
Here at Artixio, we provide comprehensive services which includes regulatory affairs, product registration, label, artwork, market access, post market entry and maintenance services and many more in the life science sector. Our expertise is spread across key life science industries like Pharmaceuticals, Medical Devices, Cosmetics, Nutrition, Biologics & Veterinary. From developing a product to its commercialization is a complex process. This can get more complex with constantly evolving rules and regulations of HSA. Artixio has a team of experts who are best in guiding through the complexities of regulatory compliance.
Our understanding gained through all the experiences helps us and serves you in detangling the HSA regulations and the challenges arising from the need to comply with them. The testing and quality services we provide assure a safe, effective and quality formation of the product. At Artixio, each member is outcome driven. This mentality has fueled us to great heights and has paved the way for faster results and increased success rate of our clients.
Our Services in Singapore
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Us For Regulatory Compliance Services in Singapore?
In-hand experts in life science services in Singapore
Quality, reliability and timely services
Customized assistance as per your needs
Proper understanding and streamlined navigation through challenges.
Continuous assistance until success.
Expedited marketing
FAQs
What are the 3 clusters in Singapore public healthcare system?
National Healthcare Group (NHG) for Central region, Singapore Health services (SHS) for Easter region and National University Health System (NUHS) for Western region. Initially it was six clusters in Singapore which was restructured into 3 in January 2017.
What are HSA’s reference drug regulatory agencies?
The reference drug regulatory agencies for HSA are Food and Drug Administration (FDA – US), European Medicines Agency (EMA – European Union), Health Canada (HC – Canada), Medicines and Healthcare Products Regulatory Agency (MHRA – UK), Swissmedic (Switzerland) & Therapeutic Goods Administration (TGA – Australia).
What is PRISM system of HSA?
PRISM stands for Pharmaceutical Regulatory Information System. It is an e-service system of the HSA. PRISM is the online platform that is used to make applications for product approval by HSA. The user can apply, track or withdraw the application, cancel or amend the registration or licence, renew licence, retain registration and search for related information are the services that PRISM supports.
What does MEDICS stands for?
MEDICS expands to Medical Device Information Communication System. Similar to PRISM, MEDICS is an online portal of HSA for the licensing and registration of medical devices in Singapore and to view information regarding medical devices.
How to report adverse events in Singapore?
HSA provides an online submission as well as manual submission methods to report adverse events. HSA’s official website provides an option to report adverse events. E forms are available for all the products and for manual submissions, the form corresponding to the product type must be downloaded from the website.
Industries We Serve in the Singapore
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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