Artificial intelligence is reshaping Pharmaceutical research and development, regulatory affairs, and clinical operations at a pace that few industries have previously experienced. From AI-accelerated drug discovery and predictive Clinical Trial design to...

Drug approval is the beginning of a Pharmaceutical company's regulatory obligation — not its culmination. Once a product receives marketing approval, an extensive and ongoing set of post-marketing requirements comes into effect:...

Recombinant Therapeutics and Monoclonal antibodies (mAbs) represent the fastest-growing and highest-value segment of the global Biological Medicines market. India's mAb market is expanding rapidly, driven by biosimilar development, originator launches, and the...

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...

India occupies a unique position in the global vaccine ecosystem — simultaneously the world's largest vaccine manufacturer by volume (producing approximately 60% of the world's vaccines), a significant importer for specialised products,...