Regulatory Affairs
Regulatory Affairs
Our team of regulatory affair experts are well versed with global regulatory requirements.
• We can provide dossiers matching following categories:
• Common Technical Document (CTD)
• Asean Common Technical Document (ACTD)
• Electronic Common Technical Document (eCTD)
• Country Specific Dossiers
• We offer regulatory support towards dossier queries from Authorities.
• Variation filing with regulatory bodies according to changing guidelines.
• Readily available dossiers, both CTD as well as ACTD for our complete range of products give us a competitive edge, enabling us to register majority of our products and dossiers in various
countries and regions across the globe.
