# -------------------------------------------- # CITATION file created with {cffr} R package # See also: https://docs.ropensci.org/cffr/ # -------------------------------------------- cff-version: 1.2.0 message: 'To cite package "r4subprofile" in publications use:' type: software license: MIT title: 'r4subprofile: Regulatory Submission Profiles for Clinical Submission Readiness' version: 0.1.1 doi: 10.32614/CRAN.package.r4subprofile 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. authors: - family-names: Mali given-names: Pawan Rama email: prm@outlook.in orcid: https://orcid.org/0000-0001-7864-5819 repository: https://r4sub.r-universe.dev repository-code: https://github.com/R4SUB/r4subprofile commit: bf904baba3ea233d2289f51ae404c377802e773e url: https://r4sub.github.io/r4subprofile/ date-released: '2026-03-16' contact: - family-names: Mali given-names: Pawan Rama email: prm@outlook.in orcid: https://orcid.org/0000-0001-7864-5819