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.

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