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ScottGab
@scottgabriel2
Regulatory Affairs Specialist and eCTD Dossier Publishing Expert
Reino Unido
Inglês
Sobre mim
Regulatory Affairs Specialist specializing in global dossier compilation and eCTD publishing. I help pharma and biotech companies format, validate, and submit compliant data to secure fast health authority approvals.
My expertise includes:
• eCTD XML lifecycle sequences
• ICH CTD (Modules 1-5) & ACTD formatting
• Technical Writing & CMC (Module 3) compilation
• Regulatory Gap Analysis to prevent delays
Experienced with compliance frameworks for US FDA, EMA, PMDA, TGA, and UAE MOH. I ensure flawless technical alignment to pass gatekeeping smoothly. Let's work together!
Habilidades
ScottGab
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Tempo médio de resposta: 1 hora
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I will format ctd dossiers for US fda ema pmda tga and uae moh
