An overview of the drug approval process of the Investigational New Drug (IND) and New Drug Application (NDA) submissions has been explored. The whitepaper discusses the differences between the two regulatory submissions and their review processes. It also compares the timelines for IND and NDA submissions in the United States (US) and the European Union (EU). The paper explores different approaches that drug sponsors can adopt to expedite the approval process and reduce the time to market the drug while maintaining compliance with regulatory requirements.
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