Our expertise

Pharmaceutical
regulatory affairs consulting

EMA, FDA & AEMPS submissions — senior expertise at every stage

Pharmaceutical Regulatory Affairs Consultant

EMA GMP Annex 1 ICH AEMPS FDA

Pharmaceutical regulatory affairs demands consistency from early development through to post-approval lifecycle management. AML Global prepares CTD/eCTD dossiers, manages IND and CTA submissions, and handles EMA and national authority filings — including AEMPS and MHRA liaison. Our GMP compliance consulting covers EU GMP Annex requirements and ICH standards, supporting manufacturers through inspection preparation, gap analysis, and supplier qualification. The same senior team handles the full lifecycle.

What's included
Regulatory strategy & gap analysis
GMP compliance & audit support
CTD/eCTD dossier preparation
EMA & national authority submissions
AEMPS & MHRA liaison
Lifecycle management & variations
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