Assessment of national regulatory guidelines and procedure assessment for the approval of a client’s therapy
A large client based in Europe, involved in Dermatology arena with a market-ready product, aimed to assess the Indian Regulatory Scenario to successfully file the product in CDSCO. They wished to identify the guidelines of approval, assess the documentation needed in India, and need for conducting clinical trials and post-market surveillance processes. The client involved DelveInsight to help them understand the overall regulatory scenario by providing effective and in-depth research into CDSCO’s latest reviews process for approval of pharmaceutical products
DUnderstand regulatory framework of different regulatory bodies across the globe, and simplify approval process
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