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Informative Article | Pharmaceutical Science | India | Volume 13 Issue 2, February 2024 | Rating: 6.7 / 10
Transformation of Regulatory Content Management in Pharma
Rita Shah
Abstract: In pharmaceutical industry, managing regulatory content is challenging due to evolving regulations, growing demand of data and content, reusability of data or content across various functions, management of different versions of content and usage of right version across various functions. As a result, there is an impact on business objectives like quality and compliance, target time to submission, right first - time submission, and time to market. Hence, there is a need for the implementation of smarter ways to manage regulatory content in future. This paper describes smarter ways to manage content and enable faster and quality submissions for early to market a drug
Keywords: Pharmaceutical Industry, Regulatory Content Management, Compliance, eCTD Submission, Drug Approval Process
Edition: Volume 13 Issue 2, February 2024,
Pages: 6 - 10