r4subprofile defines regulatory submission profiles for the R4SUB clinical submission readiness ecosystem. Each profile bundles authority-specific pillar weights, decision thresholds, required indicators, and risk configuration for a given regulatory authority and submission type.
Supported Authorities
| Authority | Region | Submission Types |
|---|---|---|
| FDA | United States | IND, NDA, BLA, ANDA, 505b2 |
| EMA | European Union | CTA, MAA, variation |
| PMDA | Japan | CTN, NDA_JP |
| Health_Canada | Canada | CTA_CA, NDS |
| TGA | Australia | CTN_AU, registration |
| MHRA | United Kingdom | CTA_UK, MAA_UK |
Quick Start
library(r4subprofile)
# Browse supported authorities
list_authorities()
list_submission_types("FDA")
# Create a submission profile
prof <- submission_profile("FDA", "NDA")
prof$pillar_weights
prof$required_indicators
# Extract configs for downstream packages
sci_cfg <- profile_sci_config(prof)
risk_cfg <- profile_risk_config(prof)
# Validate evidence against profile requirements
val <- validate_against_profile(evidence, prof)
val$is_compliant
val$missing_indicatorsIntegration with r4subscore
library(r4subscore)
library(r4subprofile)
prof <- submission_profile("EMA", "MAA", study_phase = "Phase3")
pillar_scores <- compute_pillar_scores(evidence, config = profile_sci_config(prof))
sci <- compute_sci(pillar_scores, config = profile_sci_config(prof))Key Functions
| Function | Purpose |
|---|---|
submission_profile() |
Create a regulatory submission profile |
list_authorities() |
List all supported regulatory authorities |
list_submission_types() |
List valid submission types for an authority |
profile_sci_config() |
Extract SCI config (r4subscore compatible) |
profile_risk_config() |
Extract risk config (r4subrisk compatible) |
profile_required_indicators() |
Get mandatory indicators for a profile |
validate_against_profile() |
Check evidence completeness vs profile |
profile_summary() |
Tidy tibble summary of a profile |