r4subprofile (version 0.1.0)

submission_profile: Create a Submission Profile

Description

Constructs a regulatory submission profile with authority-specific pillar weights, decision bands, required indicators, and risk configuration.

Usage

submission_profile(authority, submission_type, study_phase = NULL)

Value

A list of class "submission_profile" with elements: authority, full_name, country, submission_type, study_phase, pillar_weights, bands, required_indicators, required_asset_types, minimum_coverage, rpn_bands, default_detectability.

Arguments

authority

Character. Regulatory authority name (e.g., "FDA", "EMA"). See list_authorities() for all supported values.

submission_type

Character. Submission type for the authority (e.g., "NDA", "MAA"). See list_submission_types() for valid values.

study_phase

Character or NULL. Optional study phase (e.g., "Phase1", "Phase2", "Phase3", "Phase4"). Currently informational.

Examples

prof <- submission_profile("FDA", "NDA")
prof$pillar_weights
prof$required_indicators

prof_ema <- submission_profile("EMA", "MAA", study_phase = "Phase3")
prof_ema$bands