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regulatory-submission

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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.

When to use

• Preparing FDA/EMA regulatory submissions (IND/NDA/BLA/510(k)/PMA/MAA)
• The user mentions regulatory submission, FDA, EMA, IND, NDA, BLA, CTD, dossier, or regulatory affairs
• Generating CTD module outlines and compliance checks for dossier assembly

When not to use

• Tasks outside the documented scope
• Requests missing critical inputs
• Requests requiring unsupported assumptions

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