s
shreya1299

Shreya A

@shreya1299
Reino Unido
Inglés
Parte de la información aparece en idioma inglés.
Sobre mí
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.... Lee más

Habilidades

s
shreya1299
Shreya A
desconectado • 

Revisa mis servicios

Escritura técnica
I will write and optimize mhra and eu regulatory ectd documents