MYdossier is a global leader in regulatory consulting and dossier solution for export registration. We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline).
The Asean Common Technical Document (ACTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the ASEAN of Technical Requirements for Registration of Pharmaceuticals for Human Use.
We prepare all modules of Common Technical Document:
Part I: Administrative information
Part II: Quality
Part III: Nonclinical Study Reports
Part IV: Clinical Study Reports
We are capable to prepare dossier for more than 90 countries.
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