r4subprofile: Regulatory Submission Profiles for Clinical Submission Readiness

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Authors: Pawan Rama Mali
Cited by: 0

Abstract

Defines submission profiles per regulatory authority with authority-specific pillar weights, decision thresholds, indicator requirements, and risk configuration. Supports the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Therapeutic Goods Administration (TGA), and Medicines and Healthcare products Regulatory Agency (MHRA). Integrates with 'r4subscore' and 'r4subrisk' configuration systems.

Fields of Study & Subjects

Healthcare Regulation Pharmaceutical industry and healthcare Pharmaceutical studies and practices

Publication details

Publication date
3 March 2026
Language
EN
Document type
Dataset