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.