r4subprofile

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.

Installation

pak::pak("R4SUB/r4subprofile")

Supported Authorities

Authority	Country	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 authorities
list_authorities()
list_submission_types("FDA")

# Create a profile
prof <- submission_profile("FDA", "NDA")
prof$pillar_weights
prof$required_indicators

# Extract configs compatible with r4subscore / r4subrisk
sci_cfg  <- profile_sci_config(prof)
risk_cfg <- profile_risk_config(prof)

# Validate evidence against profile requirements
result <- validate_against_profile(evidence, prof)
result$is_compliant
result$missing_indicators

Integration with R4SUB Packages

library(r4subscore)
library(r4subprofile)

prof <- submission_profile("FDA", "NDA")

# Use profile weights for SCI computation
pillar_scores <- compute_pillar_scores(evidence, config = profile_sci_config(prof))
sci <- compute_sci(pillar_scores, config = profile_sci_config(prof))

Exported 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 configuration (r4subscore compatible)
profile_risk_config()	Extract risk configuration (r4subrisk compatible)
profile_required_indicators()	Get mandatory indicators for a profile
validate_against_profile()	Check evidence completeness vs profile
profile_summary()	Print formatted profile summary

License

MIT