Bringing a medical device to market is only the beginning. Once a product is in use, manufacturers must continue monitoring its safety, performance, and real-world impact through post-market surveillance (PMS). Post-market surveillance enables manufacturers to identify emerging risks, address product […]
A single mistranslation in a patent claim can invalidate years of work and billions in R&D investment. When it comes to pharmaceutical patents in global markets, protection is only as strong as its weakest translation, its most vulnerable jurisdiction, or
A single mistranslated word in a clinical trial protocol can delay regulatory approval by months, while inconsistent terminology across submissions can derail market access entirely. In life sciences, regulatory translation isn’t about converting words between languages, but about maintaining scientific
Most pharmaceutical companies expanding into the Asia-Pacific make the same mistake of treating APAC clinical trials like extensions of their Western operations, just with different languages. Then they wonder why regulatory submissions stall, patient recruitment collapses, and site performance varies
The Electronic Common Technical Document (eCTD) is the global standard for regulatory submissions to health authorities. It uses a structured digital format that improves efficiency and consistency across regions, although each region still has its own requirements. As the world’s
Decentralized clinical trials are reshaping how pharmaceutical and biotech companies conduct research. Instead of requiring patients to visit physical trial sites, DCTs bring the trial to patients via telemedicine, home health visits, wearable devices, and remote monitoring. The approach offers
Taiwan continues to position itself as a fast-growing medical device market in Asia. Supported by a strong healthcare system, an aging population, and rising demand for advanced technologies, the sector is expanding steadily. With a projected compound annual growth rate
The global medical devices market was valued at USD 572.31 billion in 2025 and is projected to grow from USD 604.99 billion in 2026 to USD 1,032.66 billion by 2034, exhibiting a CAGR of 6.90%. That growth represents a complete
Expanding into international markets isn’t optional for pharmaceutical companies but a necessary step towards growth. However, major regions like the US, EU, and Japan each have their regulators, which adds complexity to regulatory translation processes. For companies looking to penetrate
China’s medical device market continues to expand, driven by increasing demand and regulatory modernization. According to Fortune Business Insights, the market was valued at USD 40.31 billion in 2024 and is projected to reach USD 82.02 billion by 2032, with
80% of clinical trials fail to meet their original enrollment deadlines. These delays aren’t mere weeks, but rather months or even years. In fact, 55% of trials are terminated entirely due to insufficient patient enrollment. The global clinical trials market
Thailand is a rapidly growing medical device market in Southeast Asia, driven by an aging population and a thriving medical tourism industry. Millions of international patients seek advanced, affordable healthcare, driving demand for diagnostic tools, monitoring equipment, and long-term care
