About This Skill

Important: This skill provides structured reference information and workflow guidance for regulatory submissions. It is not legal or regulatory advice and does not replace official ICH, FDA, or EMA sources or formal regulatory review. Always confirm against the current official guideline text before making submission decisions. What this skill does (six tools): 1. ICH guideline lookup — Look up a supported ICH guideline by code and return its scope, key requirements, and official ICH URL. Currently covers a curated set of commonly referenced guidelines: E6(R3), E8(R1), M4(R4), M7(R2), M9, S1B(R1), Q1A(R2), and Q3D(R2). 2. CTD/eCTD module mapping — Map a document type or data package to its corresponding CTD/eCTD module and section (Modules 1-5), with support for NDA, BLA, MAA, and JNDA structures. 3. CTD completeness check — Compare a list of sections you have already prepared against the expected sections for a chosen module and submission type, and surface the gaps. 4. Agency deficiency guidance — Retrieve commonly cited FDA and EMA deficiency areas by domain (CMC, Clinical, Labelling, Pharmacovigilance) from a built-in reference set, to help anticipate reviewer concerns. 5. Submission readiness checklist — Generate an ordered checklist for NDA (FDA), MAA (EMA), or IND (FDA) preparation. 6. Preliminary ICH compliance check — Run a structured, preliminary check of a described study, process, or document against guideline requirements, returning a per-requirement status. Who it's 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 About the author: Built by a medical-communications practitioner with a background in pharmaceutical regulatory writing. The content is drawn from publicly available ICH guidelines and standard CTD/eCTD structure. Reminder: Outputs are intended as a starting point and quality aid, not a substitute for current official guideline text or qualified regulatory review.