regsub-mcp
regsub-mcp
MCP server for regulatory submission intelligence — ICH guideline lookup, CTD module mapping, eCTD structure guidance, and FDA/EMA query support
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Available Tools
6 toolscheck_ctd_completenessA
Check a list of provided CTD sections against required sections and identify gaps.
| Name | Required | Description | Default |
|---|---|---|---|
| provided_sections | Yes | List of CTD sections already prepared | |
| submission_type | Yes | Target submission type: 'NDA', 'BLA', or 'MAA' | |
| module | Yes | Which module to check: '3', '4', or '5' |
TDQS
Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?
In the absence of annotations, the description must disclose behavioral traits. It states it 'identifies gaps' but does not describe side effects, return format, or whether the tool is read-only. For a validation tool, this is moderately transparent but lacks specifics.
Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.
Is the description appropriately sized, front-loaded, and free of redundancy?
The description is a single, concise sentence with no unnecessary words or complexity. It efficiently conveys the tool's purpose without fluff.
Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.
Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?
For a tool with three parameters, no nested objects, and no output schema, the description should at least hint at the return format (e.g., list of missing sections). It does not, making the contextual information slightly incomplete.
Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.
Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?
Schema coverage is 100% with descriptions for all three parameters. The description adds no additional parameter-level details beyond restating the purpose. Baseline score of 3 applies as schema does the heavy lifting.
Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.
Does the description clearly state what the tool does and how it differs from similar tools?
The description clearly specifies the action ('Check a list... against required sections and identify gaps') and the resource (CTD sections). It effectively distinguishes from sibling tools like check_ich_compliance (ICH focus) and map_ctd_section (single section mapping).
Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.
Does the description explain when to use this tool, when not to, or what alternatives exist?
No explicit guidance on when to use this tool versus alternatives such as check_ich_compliance or generate_submission_checklist. The description implies a scenario (having a list of sections) but does not provide exclusions or context for when not to use it.
Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.
check_ich_complianceB
Check a description of a study or document against ICH guideline requirements and return a compliance assessment.
| Name | Required | Description | Default |
|---|---|---|---|
| description | Yes | Description of the study or document to assess | |
| guideline_code | Yes | ICH guideline to check against, e.g. 'E6(R3)', 'Q1A(R2)' |
TDQS
Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?
With no annotations, the description carries the full burden for behavioral disclosure. It mentions the tool returns a compliance assessment but does not specify whether it is read-only, what side effects exist, or any rate limits. For a check tool, essential details are missing.
Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.
Is the description appropriately sized, front-loaded, and free of redundancy?
The description is a single, well-structured sentence that immediately states the verb and resource. It is front-loaded and contains no extraneous information, making it highly concise.
Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.
Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?
The description covers the core function but lacks details on the output format of the compliance assessment (since no output schema is provided). It also does not mention prerequisites or dependencies. For a simple tool, it is adequate but not complete.
Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.
Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?
Schema coverage is 100%, so parameters are fully described in the schema. The description adds no new semantic detail beyond the schema; it simply restates the overall purpose. Baseline 3 is appropriate.
Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.
Does the description clearly state what the tool does and how it differs from similar tools?
The description clearly states the tool checks a study/document description against ICH guidelines and returns a compliance assessment. It distinguishes from siblings like lookup_ich_guideline (simply looks up a guideline) and check_ctd_completeness (checks CTD completeness, not compliance).
Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.
Does the description explain when to use this tool, when not to, or what alternatives exist?
No guidance is provided on when to use this tool versus alternatives (e.g., when to use check_ctd_completeness instead). The description only states what it does without recommending or excluding scenarios.
Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.
generate_submission_checklistB
Generate a submission readiness checklist for a given submission type and agency.
| Name | Required | Description | Default |
|---|---|---|---|
| submission_type | Yes | Type: 'NDA', 'BLA', 'MAA', 'IND', 'CTA', 'IMPD' | |
| agency | Yes | Target agency: 'FDA', 'EMA', 'PMDA', 'Health Canada' |
TDQS
Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?
With no annotations provided, the description carries full burden for behavioral disclosure. It does not state whether the operation is read-only, what side effects exist, permission requirements, or the output format. For a generation tool, additional context about the checklist's structure or delivery mechanism would be beneficial.
Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.
Is the description appropriately sized, front-loaded, and free of redundancy?
The description is a single concise sentence that immediately conveys the tool's purpose. It is front-loaded and contains no unnecessary words.
Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.
Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?
Given no output schema and no annotations, the description lacks details about the checklist's format, content, or limitations. For a simple tool with two string parameters, it is minimally adequate but leaves the agent without expectations of what to receive.
Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.
Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?
Schema description coverage is 100%, so the schema already documents both parameters. The description adds no extra meaning beyond what the schema provides. Baseline score of 3 is appropriate.
Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.
Does the description clearly state what the tool does and how it differs from similar tools?
The description clearly states the action ('generate'), the resource ('submission readiness checklist'), and the inputs ('submission type and agency'). This effectively distinguishes it from sibling tools like check_ctd_completeness or lookup_ich_guideline, which serve different purposes.
Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.
Does the description explain when to use this tool, when not to, or what alternatives exist?
The description provides no guidance on when to use this tool versus alternatives. It does not mention scenarios, prerequisites, or contrast with sibling tools. The agent must infer usage from the tool name and context alone.
Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.
get_agency_deficiency_guidanceA
Retrieve common deficiency areas for FDA or EMA submissions by domain (CMC, Clinical, Labelling, Pharmacovigilance).
| Name | Required | Description | Default |
|---|---|---|---|
| agency | Yes | Regulatory agency: 'FDA' or 'EMA' | |
| domain | Yes | Area: 'CMC', 'Clinical', 'Labelling', or 'Pharmacovigilance' |
TDQS
Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?
With no annotations, description must fully disclose behavior. Only states 'Retrieve' implying read-only, but omits details like data freshness, auth requirements, rate limits, or error behavior.
Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.
Is the description appropriately sized, front-loaded, and free of redundancy?
Single sentence, front-loaded, no unnecessary words. Efficiently conveys core purpose.
Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.
Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?
Adequate for a simple two-parameter lookup, but lacks information about return structure (since no output schema) and any pagination or limits.
Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.
Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?
Schema covers both parameters with descriptions; description adds no new meaning beyond repeating the enum values already in schema.
Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.
Does the description clearly state what the tool does and how it differs from similar tools?
Description clearly states verb 'Retrieve', resource 'common deficiency areas for FDA or EMA submissions', and scope 'by domain'. It distinguishes from sibling tools which focus on compliance checks and ICH guidelines.
Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.
Does the description explain when to use this tool, when not to, or what alternatives exist?
Implied usage for retrieving FDA/EMA deficiency guidance per domain but no explicit when-to-use or when-not-to-use guidance, and no mention of alternatives among siblings.
Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.
lookup_ich_guidelineA
Look up an ICH guideline by code (e.g. E6(R3), M4, Q1A). Returns scope, key requirements, and official URL.
| Name | Required | Description | Default |
|---|---|---|---|
| guideline_code | Yes | ICH guideline code, e.g. 'E6(R3)', 'M4(R4)', 'Q3D(R2)', 'M7(R2)' |
TDQS
Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?
No annotations are provided, and the description only states what the tool returns without disclosing behavioral details like error handling, case sensitivity, or response format. This is insufficient for a tool without annotations.
Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.
Is the description appropriately sized, front-loaded, and free of redundancy?
The description is a single concise sentence with two clear clauses, no redundant information, and front-loaded purpose.
Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.
Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?
Given the simple tool (one parameter, no output schema), the description adequately covers what it does and returns. It lacks details on invalid codes but is otherwise complete.
Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.
Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?
Schema coverage is 100% with a descriptive parameter comment. The description's examples (e.g., E6(R3), M4, Q1A) add marginal value beyond the schema, so baseline 3 is appropriate.
Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.
Does the description clearly state what the tool does and how it differs from similar tools?
The description clearly states the verb 'look up', the resource 'ICH guideline', and the method 'by code'. It distinguishes itself from sibling tools like check_ich_compliance, which involve different operations.
Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.
Does the description explain when to use this tool, when not to, or what alternatives exist?
The description implies the tool is for retrieving guideline details by code, but does not explicitly state when to use it vs. alternatives or provide exclusions. The purpose is clear but guidance is minimal.
Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.
map_ctd_sectionA
Map a document type or data package to the correct CTD/eCTD module and section. Returns the full section hierarchy.
| Name | Required | Description | Default |
|---|---|---|---|
| module | Yes | CTD module number: '1', '2', '3', '4', or '5' | |
| submission_type | No | Submission type: 'NDA', 'BLA', 'MAA', or 'JNDA' |
TDQS
Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?
No annotations are provided, so the description must carry the burden of behavioral disclosure. It states the function returns a hierarchy but does not mention side effects, authentication needs, error handling, or whether the operation is read-only. While adequate for a simple mapping, it lacks depth.
Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.
Is the description appropriately sized, front-loaded, and free of redundancy?
The description is two short sentences: one defining the purpose and one stating the return value. It is front-loaded, concise, and contains no superfluous information.
Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.
Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?
The tool has two parameters, no output schema, and no annotations. The description explains the purpose and return value, but it does not specify the format of the returned hierarchy or behavior when the optional submission_type is omitted. Given the tool's simplicity, the description is adequate but not fully complete.
Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.
Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?
Schema coverage is 100%, with each parameter described in the input schema. The description adds context that the tool maps to CTD sections, but it does not provide additional meaning beyond what the schema already offers. Hence, the baseline score of 3 is appropriate.
Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.
Does the description clearly state what the tool does and how it differs from similar tools?
The description clearly states the tool maps a document type or data package to the correct CTD/eCTD module and section, using the verb 'Map' and specifying the resource. It also mentions returning the full section hierarchy. This distinguishes it from sibling tools like check_ctd_completeness, which focus on validation.
Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.
Does the description explain when to use this tool, when not to, or what alternatives exist?
The description implies usage when needing to determine the correct CTD section for a document, and it notes the output includes the full hierarchy. However, it does not explicitly state when not to use this tool or mention alternatives among siblings, which could be more helpful.
Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.
Tool Schema Changelog
Recent tool additions, removals, and schema changes observed during successful MCP inspections. Dates show when Glama detected each change.
6 tool updates
- First observed
check_ctd_completeness - First observed
check_ich_compliance - First observed
generate_submission_checklist - First observed
get_agency_deficiency_guidance - First observed
lookup_ich_guideline - First observed
map_ctd_section
TDQS
Each tool targets a distinct function: completeness checking, compliance assessment, checklist generation, deficiency guidance, guideline lookup, and CTD section mapping. No overlap.
All tool names follow a consistent verb_noun pattern with snake_case (e.g., check_ctd_completeness, lookup_ich_guideline), making them predictable and easy to parse.
With 6 tools, the set is well-scoped for the regulatory submission domain, covering essential actions without being overwhelming or too sparse.
The tools cover key workflows: checking compliance, mapping sections, generating checklists, and retrieving guidance. Minor gaps exist (e.g., no tool for direct submission or formatting), but these are acceptable given the advisory focus.
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