Getting a new drug, biologic, or medical device to market is not a quick process. One of the biggest questions sponsors ask is simple: how long will this take? The answer depends on many factors, but understanding the key milestones can help you plan better and avoid surprises. In this blog, we have broken down what happens […]
Running a clinical trial in more than one country can help sponsors reach a wider patient population and collect data from different markets. However, it also makes the regulatory process more complex. Each country may follow its own rules, review procedures, document requirements, and ethics approval process. A regulatory submission that is accepted in one market may […]
A successful regulatory submission to the FDA begins long before a sponsor uploads documents through the Electronic Submissions Gateway. Many delays are not caused by weak science, but by early gaps in regulatory strategy, incomplete submission documents, inconsistent clinical data, poor eCTD planning, or delayed cross-functional coordination. For pharma, biotech, medical device, and CRO teams, regulatory submission cannot be just an online filing […]
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 […]
