Regulatory Submission Intelligence

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Regulatory Submission Intelligence

Expert-curated MCP tools for pharma regulatory affairs teams, CROs, and AI agents embedded in drug development workflows. Built by a CMPP-certified PhD neuroscientist with 10+ years in pharmaceutical medical communications and regulatory writing.

Tools Included

lookup_ich_guideline — Look up any ICH guideline by code (E6(R3), M4(R4), M7(R2), Q1A(R2), Q3D(R2), S1B(R1), M9, E8(R1)). Returns scope, key requirements, and official URL.

map_ctd_section — Map any document or data package to its correct CTD/eCTD module and section number. Covers all of Modules 1–5 with full subsection hierarchy for NDA, BLA, MAA, and JNDA submissions.

check_ctd_completeness — Provide your list of prepared CTD sections and get back a completeness score, list of addressed sections, and gaps that must be closed before submission.

get_agency_deficiency_guidance — Retrieve common deficiency areas for FDA or EMA submissions by domain: CMC, Clinical, Labelling, or Pharmacovigilance. Proactively address reviewer concerns before they arise.

generate_submission_checklist — Generate a full submission readiness checklist for NDA (FDA), MAA (EMA), or IND (FDA). Returns ordered checklist with all required documents, data packages, and administrative requirements.

check_ich_compliance — Describe a study, process, or document and get a preliminary compliance assessment against any supported ICH guideline, with per-requirement pass/flag status.

Who Is This For?

• Regulatory affairs professionals preparing NDA, BLA, MAA, or IND submissions
• Medical writers producing CTD summaries and overviews
• CROs and regulatory consultants advising on submission strategy
• AI agents embedded in pharma publication and regulatory workflows
• Teams building regulatory intelligence tooling

Why This Server?

Most regulatory tools require expensive software licenses or rely on generic AI with no domain expertise. This server provides structured, expert-curated guidance built on ICH guidelines and real-world submission experience — directly callable by any MCP-compatible AI agent.

Works great with

Part of the PubsPro suite for AI agents in pharma publications and regulatory workflows:

• Medical Writer's AI Toolkit — draft CTD summaries, abstracts, and plain-language summaries
• PubMed Search — pull the biomedical literature backing your submission
• MedTerms — resolve ICD-10, MedDRA, RxNorm, and CTCAE terminology used in submission documents