×

Access all guidelines and regulatory updates on

QuriousRI
×

Access all guidelines and regulatory updates on

QuriousRI

Artixio

Singapore Compliance Consulting Solutions

Our priority is the same as yours – patient safety. Artixio presents you with HSA regulatory compliance support, registration approval process support, 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.

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.

Artixio provides specialized Compliance Support in Singapore covering HSA license consultant services, regulatory submissions, and structured HSA compliance consulting services for smooth market approval.

HSA Compliance 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.

We provide HSA Authorized Agent Services in Singapore for companies seeking product registration and regulatory compliance support. Our team handles submissions, liaises with HSA, and helps manage testing and quality requirements to facilitate smoother market entry.

Singapore Compliance & Approval Consulting

Why Us For Regulatory Compliance Services in Singapore?

Compliance consulting services company
In-hand experts in life science services in Singapore
Compliance consulting services company
Quality, reliability and timely services
Compliance consulting services company
Customized assistance as per your needs
Compliance consulting services company
Proper understanding and streamlined navigation through challenges.
Compliance consulting services company
Continuous assistance until success.
Compliance consulting services company
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.
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).
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.
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.
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 Singapore

Regulatory and compliance expert – Artixio

Pharmaceuticals

Medical device regulatory services – Artixio

MedTech

Cosmetics regulatory consulting – Artixio

Cosmetics

Nutrition regulatory consulting – Artixio

Nutrition

Biologics regulatory consulting – Artixio

Biologics

Veterinary regulatory consulting – Artixio

Veterinary

Our Global Reach: Serving Life
Sciences Clients Worldwide

India Artixio – Regulatory affairs consulting expert

India

Singapore Artixio – Regulatory affairs consulting expert

Singapore

Mexico Artixio – Regulatory affairs consulting expert

Mexico

Brazil Artixio – Regulatory affairs consulting expert

Brazil

Vietnam Artixio – Regulatory affairs consulting expert

Vietnam

Malaysia Artixio – Regulatory affairs consulting expert

Malaysia

Argentina Artixio – Regulatory affairs consulting expert

Argentina

Colombia Artixio – Regulatory affairs consulting expert

Colombia

Taiwan Artixio – Regulatory affairs consulting expert

Taiwan

China Artixio – Regulatory affairs consulting expert

China

Europe Artixio – Regulatory affairs consulting expert

European

Thailand Artixio – Regulatory affairs consulting expert

Thailand

Indonesia Artixio – Regulatory affairs consulting expert

Indonesia

Philippines Artixio – Regulatory affairs consulting expert

Philippines

USA Artixio – Regulatory affairs consulting expert

USA

Japan Artixio – Regulatory affairs consulting expert

Japan

Qatar

South Korea

Insights from Artixio - Tips & Articles

HSA Guidance on Class 2 CTGTP Registration in Singapore

HSA Guidance on Class

Advanced medicines, such as cell, gene, and tissue-engineered therapies, are revolutionizing modern medicine. In...

February 24, 2026
HSA Singapore Investigational Product Management Guidance

HSA Singapore Investigational Product

For locally registered products in Singapore, the management of investigational product (IP) for clinical...

February 23, 2026
New Drugs, Generics and Biosimilars Registration in Singapore: Whitepaper on HSA Regulations

New Drugs, Generics and

Singapore stands as a beacon of regulatory excellence in the pharmaceutical industry, offering a...

February 1, 2026

Get in touch

×