The future of regulatory filings: digitalization

The future of regulatory filings: digitalization

Abstract The biopharmaceutical industry, while advancing rapidly in drug development, has lagged in the digitalization of regulatory submissions, leading to inefficiencies, delays, and increased administrative burdens. Current processes rely heavily on manual input, increasing labor burdens and the...

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Bibliographic Details
Main Authors: Kabir Ahluwalia, Michael J. Abernathy, Marquerita Algorri, Nina S. Cauchon, Natalie M. Perico-Norred, Rita Y. Albert Youssef
Format: Article
Language:English
Published: SpringerOpen 2025-04-01
Series:AAPS Open
Subjects:
Artificial intelligence
Cloud platforms
Digitalization
Regulatory affairs
Structured content
Data standards
Online Access:https://doi.org/10.1186/s41120-025-00113-7
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https://doi.org/10.1186/s41120-025-00113-7

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