Package: r4subprofile Title: Regulatory Submission Profiles for Clinical Submission Readiness Version: 0.1.1 Authors@R: person("Pawan Rama", "Mali", email = "prm@outlook.in", role = c("aut", "cre", "cph"), comment = c(ORCID = "0000-0001-7864-5819")) 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. License: MIT + file LICENSE URL: https://r4sub.github.io/r4subprofile/, https://github.com/R4SUB/r4subprofile BugReports: https://github.com/R4SUB/r4subprofile/issues Depends: R (>= 4.2) Imports: cli, r4subcore, rlang, tibble Suggests: knitr, r4subscore, r4subrisk, rmarkdown, testthat (>= 3.0.0) VignetteBuilder: knitr Config/testthat/edition: 3 Encoding: UTF-8 Roxygen: list(markdown = TRUE) RoxygenNote: 7.3.3 Config/pak/sysreqs: libxml2-dev Repository: https://r4sub.r-universe.dev Date/Publication: 2026-03-16 11:27:35 UTC RemoteUrl: https://github.com/r4sub/r4subprofile RemoteRef: HEAD RemoteSha: bf904baba3ea233d2289f51ae404c377802e773e NeedsCompilation: no Packaged: 2026-06-14 07:47:35 UTC; root Author: Pawan Rama Mali [aut, cre, cph] (ORCID: ) Maintainer: Pawan Rama Mali