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Jul 08, 2025

Tackling Grandfather or Legacy Products: A Regulatory Perspective
Jul 01, 2025

Why Reference Agency Approval Isn’t Enough for Local Registration
Jun 17, 2025

Common Deficiencies in Biologics Applications in Singapore – What Applicants Should Watch Out For

Overview of Product Defect Reporting in Singapore

Product Registrant Responsibilities In Singapore, the Marketing Authorization Holder (MAH), also known as the Product Registrant, is responsible for ensuring that products released into the market are safe and of high quality. This obligation includes pharmacovigilance (PV) activities such as monitoring safety profiles, adverse event reporting, active surveillance programs, and compiling Periodic Benefit-Risk Evaluation […]

07 Aug 2024 |
Good Distribution Practice for Pharma

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How to Ensure Good Distribution Practice for Pharma Products

As pharmaceutical products directly impact patient health and well-being, maintaining high-quality standards is essential. Medications should always be safe, effective and consistent in their therapeutic effects to avoid potential risks such as treatment failures, adverse reactions or even life-threatening consequences. This is where Good Distribution Practice (GDP) for pharmaceutical products comes in handy, guaranteeing the […]

16 Apr 2024 |
Good Distribution Practice for Pharma

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Hand picking pharmaceutical product for regulatory consulting in pharma

If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!