The Common Technical Document (CTD) is the universal language of Pharmaceutical and Biological registration. Most global regulatory agencies, including the USFDA, EMA and PMDA accept the ICH CTD format with regional Module...

One of the most consequential strategic decisions for any global Biological product company entering India is whether to proceed as an importer or establish local manufacturing. This decision has profound implications for...

Time Is Money — And Preventable Delays Are Common India's Biological product approval timelines are frequently longer than companies anticipate. While CDSCO has made significant progress in recent years — introducing electronic...

Why India's Regulatory System is Different For companies entering India with Biological products for the first time, one of the most frequent surprises is the multiplicity of Regulatory authorities involved in approval,...

Why India Demands a Dedicated Biosimilar Strategy India is one of the fastest-growing Biosimilar markets in the world, driven by a large patient population, expanding government healthcare coverage under Ayushman Bharat, and...

The Regulatory Pathway for Biologicals in India is governed by strict guidelines to ensure the safety, efficacy, and quality of biological products. Manufacturers must follow regulatory frameworks established by CDSCO and the...