r4subprofile: Regulatory Submission Profiles for Clinical Submission Readiness

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.

Version:	0.1.0
Depends:	R (≥ 4.2)
Imports:	cli, r4subcore, rlang, tibble
Suggests:	r4subscore, r4subrisk, testthat (≥ 3.0.0)
Published:	2026-03-03
DOI:	10.32614/CRAN.package.r4subprofile
Author:	Pawan Rama Mali [aut, cre, cph]
Maintainer:	Pawan Rama Mali <prm at outlook.in>
BugReports:	https://github.com/R4SUB/r4subprofile/issues
License:	MIT + file LICENSE
URL:	https://github.com/R4SUB/r4subprofile
NeedsCompilation:	no
Materials:	README, NEWS
CRAN checks:	r4subprofile results

Documentation:

Reference manual:

r4subprofile.html , r4subprofile.pdf

Downloads:

Package source:	r4subprofile_0.1.0.tar.gz
Windows binaries:	r-devel: r4subprofile_0.1.0.zip, r-release: r4subprofile_0.1.0.zip, r-oldrel: r4subprofile_0.1.0.zip
macOS binaries:	r-release (arm64): r4subprofile_0.1.0.tgz, r-oldrel (arm64): r4subprofile_0.1.0.tgz, r-release (x86_64): r4subprofile_0.1.0.tgz, r-oldrel (x86_64): r4subprofile_0.1.0.tgz

Reverse dependencies:

Reverse imports:

r4sub

Linking:

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