News & Articles

Many biologics licence applications stumble in Module 3, where CMC, stability, and quality data are closely scrutinised by the HSA. This article highlights frequent errors, their impact, and how to prevent them. With TRC’s pharma regulatory services and HSA support, we aim to help companies and marketing authorisation holders prepare accurate, compliant submissions that minimise queries and speed up approval.

We’re back for our weekly deep dive into the fascinating world of regulatory affairs! This week, I want to tackle a topic that comes up surprisingly often in my conversations with clients, especially those looking to bring life-saving products like vaccines to new markets: How do you leverage a WHO Prequalified (PQ) dossier for registration […]

Amongst the ever-emerging trend of new generation drugs, there is a group that is not widely discussed yet still remains the gold standard of treatment — or even serves as the pharmacophore on which many modern drugs are built. Examples of grandfather products include aspirin, morphine, diphenhydramine, and propranolol — all introduced decades ago and […]

Biologics in Singapore: What Makes the Dossier Different? If you’re looking to register a biologic product in Singapore, you might have noticed it’s not quite the same as other drugs. From my experience working with clients, the local authority has some specific expectations that make the dossier a bit different. The CTD format is familiar, […]

In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore […]

In today’s fast-paced society, maintaining a healthy diet has never been more relevant. Nutraceuticals, or health supplements, are becoming increasingly popular for their role in maintaining overall health and supplementing nutrients lacking in our daily diets. These products are typically derived from natural and organic sources, catering to growing interests in areas such as immunity, […]