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.

For companies navigating new drug or biologics submissions, HSA pre-submission meetings are a strategic advantage. They clarify expectations, streamline timelines, and build confidence with regulators. Explore why these meetings matter and how The Reg Consultants, a trusted regulatory affairs consultant in Singapore, supports your team with guidance, preparation, and HSA registration expertise to achieve smooth approvals.

Singapore is a strategic hub for companies seeking entry into ASEAN markets. Its strong regulatory framework, participation in mutual recognition arrangements, and efficient licensing processes provide a clear pathway to compliance. By leveraging Singapore’s position and working with a regulatory affairs consultant, businesses can align with ASEAN regulations and plan effective regional product launch strategies.

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 […]

We often get leads from prospects telling us: “My product is FDA/EMA approved, so there shouldn’t be any issue for local submission. Efforts on your end should be minimal – can we reduce costs?” I’m sure those who know the reality are quietly laughing behind their screens as I say this. Why Do We Still […]