Global expansion is no longer a strategic option for pharmaceutical and medical device companies. It is a commercial necessity. Yet, from a chief risk officer’s vantage point, global expansion is also where regulatory risk multiplies at the fastest possible rate. Across FDA-regulated markets, EU MDR territories, emerging Asia-Pacific zones, and Middle Eastern regulatory ecosystems, the […]
India’s medical device industry is on the rise. Initiatives like Make in India, paired with a rise in chronic diseases and VC funding, have helped the Indian medical device market become the 4th largest market in Asia and top 20 globally. Along with the rise in the medical device industry, regulatory expectations under UDSCO are […]
After spending a few years researching, developing, and collecting data for breakthrough therapies and novel devices, it’s important for the pharma company to get through the regulatory submissions. However, navigating the Indian regulatory system, especially under the Central Drugs Standard Control Organisation, often proves challenging due to evolving guidelines, multi-tiered requirements, and limited standardisation. Innovative […]
