News & Articles

In Singapore, regulatory submissions cannot move forward without a local authorised representative. A regulatory consultant fills this role, serving as a liaison with HSA, preventing costly errors, and managing ongoing compliance. The result? Stronger approval success, faster timelines, and peace of mind for international manufacturers entering the Singapore healthcare and pharmaceutical market. Keep reading to learn more.

Entering the pharmaceutical market in Singapore presents a complex web of regulations and requirements that companies must navigate. Market access refers to the process of making pharmaceutical products available to those who need them at the right price and time. The process involves various activities focused on ensuring patients receive the treatments they require. At […]

Brazil pharmaceutical companies offer a diverse and innovative portfolio of products. However, due to geographical distance, most companies focus on developing their market within Brazil and the U.S. There are many compelling reasons for Brazilian companies to consider expanding into Singapore and other ASEAN countries, where they can leverage strategic regulatory advantages and market opportunities […]

China’s primary regulatory authority is the National Medical Products Administration (NMPA). The pharmaceutical landscape continues to evolve globally, with different countries adopting distinct approaches to ensure the safety, quality, and efficacy of medicinal products. China and Singapore are both dynamic markets with growing demand for innovative therapies. However, their regulatory environments differ significantly and can […]

Navigating the complex world of regulatory affairs is crucial for pharmaceutical and biotech companies looking to ensure compliance while speeding up pharma market access. In Singapore’s competitive landscape, the demand for customised regulatory management has led to the rise of subscription plans tailored to companies of all sizes, from startups to big pharma. These plans […]

Accessing life-saving treatments can be challenging, particularly for those living with rare diseases. In Singapore, as in many other regions, orphan drugs — medications specifically created to treat these rare conditions — come with unique challenges regarding availability and cost. In this guide, we delve into the complex issues surrounding orphan drugs and offer a […]