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Shreya A
@shreya1299
Royaume-Uni
Anglais
À propos de moi
UK Regulatory Affairs specialist & former MHRA operative — I know what regulators want because I've worked inside the agency.
5+ years managing CMC lifecycle for 500+ licensed products across MHRA & EU markets. I've led 250+ eCTD submissions (Type IA/IB/II) and 50+ MAA dossiers. I write SmPCs, PILs, Module 1-5 documentation, and variation justifications built to get approved first time.
Compétences
Shreya A
hors ligne •
Voir mes services
Rédaction technique
I will write and optimize mhra and eu regulatory ectd documents
