Regulatory approval is often treated as the finish line. In reality, for Medical Device and IVD manufacturers in India, it marks the start of an equally demanding obligation: Post-Market Surveillance (PMS). Under...

One of the most avoidable and expensive mistakes in Medical Device commercialisation is Regulatory rework — the process of going back to redo documentation, testing, or submissions  because the original data was...

For Indian Pharmaceutical manufacturers with ambitions to supply regulated international markets - the United States, European Union, United Kingdom, Canada, and Australia — obtaining and maintaining approval from international regulatory authorities is...

For a Medical Device company that wants to expand globally, the biggest question arises is of market prioritization. Entering a market is both a regulatory challenge and a strategic decision. The three...