regulatory-submission

Prepare FDA/EMA regulatory submissions (IND/NDA/BLA/510(k)/PMA/MAA) in CTD format. Generate module outlines (Modules 1-5), run ICH compliance checks (ALCOA+, E6 GCP, Q1-Q12), verify data integrity, and produce submission-ready dossiers with cover letters and checklists.

Quality

76%

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tessl review fix ./scientific-skills/Academic Writing/regulatory-submission/SKILL.md

Quality

Content

71%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

A well-structured, concise instruction-only skill body with clear sequencing and a checkpoint, but its actionability is held to 3 because compliance-check and CTD-mapping procedures are named rather than specified.

Suggestions

Add concrete execution detail to the compliance and data-integrity steps — e.g., specify what each ICH check (E6 GCP, Q1-Q12) verifies, or how each submission type maps to required CTD modules/sections — to move actionability from 3 toward 5.

Remove the redundancy in 'Key Principles' (ICH/ALCOA+ already appear in the workflow and description) to tighten conciseness toward 5.

Add a final verification checkpoint in the 'Finalize dossier' step (e.g., verify cross-references resolve and all module placeholders are filled) to push workflow_clarity toward 5.

Dimension	Reasoning	Score
Conciseness	The body is lean and avoids explaining concepts Claude already knows (no definitions of FDA/EMA/CTD), with only minor redundancy — e.g., 'Key Principles' restates ICH/ALCOA+ already present in the workflow and description — that could be trimmed; not a 5 because of that repetition.	4 / 5
Actionability	Concrete structural guidance exists (numbered workflow with inputs/outputs, '[DATA REQUIRED]' placeholders, critical/major/minor classification, explicit error-handling directives) but key execution details are missing — e.g., 'run ICH compliance checks (E6 GCP, Q1-Q12)' does not specify what each check entails or how CTD sections map to submission types — leaving it as a framework rather than a fully executable procedure.	3 / 5
Workflow Clarity	A clear 6-step sequence with an explicit ⛔ checkpoint in step 5 plus feedback loops in 'If Data Incomplete' and 'Error Handling' (manual fallback); not a 5 because there is only one checkpoint for the full process and the finalization step lacks a final verification, and no concrete checklist artifact is provided despite mentioning checklists.	4 / 5
Progressive Disclosure	Well-organized into clearly headed sections (When to Use, Workflow, If Data Incomplete, Submission Types, CTD Format, Key Principles, Error Handling, Input Validation) with no nested references and no need for external bundle files; content is appropriately self-contained for a skill of this size.	5 / 5
	Total	16 / 20 Passed

Description

82%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A specific, well-scoped description with strong trigger terms and low conflict risk, written in correct third-person voice. Its main weakness is the missing "Use when..." trigger guidance, which caps completeness at 3.

Suggestions

Add an explicit 'Use when...' clause naming natural trigger phrases (e.g., 'Use when preparing FDA/EMA submissions, or when the user mentions IND, NDA, BLA, CTD, dossier, or regulatory affairs') to lift completeness from 3 to 5.

Optionally include 'eCTD' and 'regulatory affairs' as additional synonyms to round out trigger-term coverage.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete actions ("Generate module outlines (Modules 1-5)", "run ICH compliance checks (ALCOA+, E6 GCP, Q1-Q12)", "verify data integrity", "produce submission-ready dossiers with cover letters and checklists") with comprehensive coverage of the domain.	5 / 5
Completeness	The "what" is clearly stated but there is no "Use when..." clause or equivalent explicit trigger guidance, which per the judging guidelines caps completeness at 3; it is not a 4 because the "when" is entirely absent rather than merely implicit.	3 / 5
Trigger Term Quality	Comprehensive natural terminology a regulatory-affairs user would actually say: FDA, EMA, IND, NDA, BLA, 510(k), PMA, MAA, CTD, dossier, plus ICH/ALCOA+ synonyms across submission types and both agencies.	5 / 5
Distinctiveness Conflict Risk	Occupies a clear niche (FDA/EMA regulatory submissions in CTD format) with distinct, specialized triggers that are unlikely to fire for unrelated skills, giving minimal conflict risk.	5 / 5
	Total	18 / 20 Passed

Validation

93%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 15 / 16 Passed

Validation for skill structure

Criteria	Description	Result
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning

	Total	15 / 16 Passed

Repository: aipoch/medical-research-skills
Path: scientific-skills/Academic Writing/regulatory-submission/SKILL.md
Commit: f5ef65b

Reviewed: ~22 hours ago

Table of Contents

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