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r4subprofile  

Regulatory Submission Profiles for Clinical Submission Readiness
View on CRAN: Click here


Download and install r4subprofile package within the R console
Install from CRAN:
install.packages("r4subprofile")

Install from Github:
library("remotes")
install_github("cran/r4subprofile")

Install by package version:
library("remotes")
install_version("r4subprofile", "0.1.0")



Attach the package and use:
library("r4subprofile")
Maintained by
Pawan Rama Mali
[Scholar Profile | Author Map]
All associated links for this package
First Published: 2026-03-03
Latest Update: 2026-03-03
Description:
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.
How to cite:
Pawan Rama Mali (2026). r4subprofile: Regulatory Submission Profiles for Clinical Submission Readiness. R package version 0.1.0, https://cran.r-project.org/web/packages/r4subprofile. Accessed 06 Jun. 2026.
Previous versions and publish date:
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Complete documentation for r4subprofile
Functions, R codes and Examples using the r4subprofile R package
Full r4subprofile package functions and examples
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