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.
Versions across snapshots
| Version | Repository | File | Size |
|---|---|---|---|
0.1.0 |
rolling linux/jammy R-4.5 | r4subprofile_0.1.0.tar.gz |
41.0 KiB |
0.1.0 |
rolling linux/noble R-4.5 | r4subprofile_0.1.0.tar.gz |
40.9 KiB |
0.1.0 |
rolling source/ R- | r4subprofile_0.1.0.tar.gz |
11.9 KiB |
0.1.0 |
latest linux/jammy R-4.5 | r4subprofile_0.1.0.tar.gz |
41.0 KiB |
0.1.0 |
latest linux/noble R-4.5 | r4subprofile_0.1.0.tar.gz |
40.9 KiB |
0.1.0 |
latest source/ R- | r4subprofile_0.1.0.tar.gz |
11.9 KiB |
0.1.0 |
2026-04-26 source/ R- | r4subprofile_0.1.0.tar.gz |
11.9 KiB |
0.1.0 |
2026-04-23 source/ R- | r4subprofile_0.1.0.tar.gz |
11.9 KiB |
0.1.0 |
2026-04-09 windows/windows R-4.5 | r4subprofile_0.1.0.zip |
44.3 KiB |