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The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications — applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened — most study reports are not required to be submitted.
The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States. Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
PharmaActdDossiers staff has extensive medical writing experience including Pre-Clinical and Clinical Study Reports, INDs, Fast Track Applications, New Drug Molecules and clinical summaries for Safety and Efficacy, ACTD, CTD and eCTD submission format.
Pharma Actd Dossiers
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