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Server Configuration

Describes the environment variables required to run the server.

NameRequiredDescriptionDefault

No arguments

Capabilities

Features and capabilities supported by this server

CapabilityDetails
tools
{}

Tools

Functions exposed to the LLM to take actions

NameDescription
lookup_ich_guidelineA

Look up an ICH guideline by code (e.g. E6(R3), M4, Q1A). Returns scope, key requirements, and official URL.

map_ctd_sectionC

Map a document type or data package to the correct CTD/eCTD module and section. Returns the full section hierarchy.

check_ctd_completenessB

Check a list of provided CTD sections against required sections and identify gaps.

get_agency_deficiency_guidanceA

Retrieve common deficiency areas for FDA or EMA submissions by domain (CMC, Clinical, Labelling, Pharmacovigilance).

generate_submission_checklistB

Generate a submission readiness checklist for a given submission type and agency.

check_ich_complianceB

Check a description of a study or document against ICH guideline requirements and return a compliance assessment.

Prompts

Interactive templates invoked by user choice

NameDescription

No prompts

Resources

Contextual data attached and managed by the client

NameDescription

No resources

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