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Über mich
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.... Mehr lesen