Pharmaceutical
Skill packages tagged with “Pharmaceutical”
Annex 1 CCS Validator
Draft and validate a Contamination Control Strategy (CCS) for pharmaceutical sterile manufacturing per EU GMP Annex 1 (2023). Maps cleanroom classifications to grades A/B/C/D, validates environmental monitoring limits against the stricter 2023 microbial thresholds, and checks airflow patterns, pressure cascades, and CCS element coverage.
Biotech Dossier Expert — Terapias Avançadas (ANVISA)
Elaboração do dossiê técnico para registro de produtos de terapias avançadas (células, tecidos, terapias gênicas). Organiza documentação de CQ, esterilidade e dados clínicos conforme RDC 338/2020 e Agenda Regulatória 2026. Inclui validação de integridade aséptica.
eCTD Cross-Module Verifier
Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, endpoints, and safety data are aligned before regulatory submission to FDA, EMA, or PMDA.
GMP SOP & Validation Author
Guided elaboration of GMP documentation — SOPs, validation protocol (IQ/OQ/PQ), and batch record template sections aligned to FDA 21 CFR 211 / EU EudraLex Vol 4 / WHO GMP.