Regulatory Submissions & Evidence Packages (FDA/EMA) | eCTD, CDISC & Inspection Readiness

Prepare audit-ready evidence packages for FDA/EMA: eCTD structure, CDISC SDTM/ADaM, SAP & TLFs, validation & traceability, RWD/RWE dossiers, benefit–risk narratives, and inspection readiness for clinical bioinformatics.

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Regulatory Submissions & Evidence Packages (FDA/EMA) — Hands-on

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