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Herbal Dossier Compiling / Writing\r\n\r\nHerbal drugs are getting higher acceptance as an alternative medicine. Therefore some countries have started the registration for herbal drugs as well. Recently we are working on compiling and writing herbal dossiers too.\r\nPharma CTD / ACTD Dossier\r\n\r\nDrug regulatory affairs in pharma industries has mandated two types of dossier namely CTD ( Common Technical Dossier) and ACTD ( Asian Common Technical Dossier ). Regulated pharma markets (eg.USA, Europe ) markets require submission of dossier in CTD format which has to provide clinical trial and bioequivalence studies. As against this, semi-regulated pharma markets (South East Asian and Gulf Countries) require ACTD format which does not require exhaustive details like CTD.
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dossier services, regulatory affairs service