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 Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

We prepare all modules of Common Technical Document:

Module 1. Administrative information and prescribing information

Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)

Module 3. Quality

Module 4. Nonclinical Study Reports (toxicology studies)

Module 5. Clinical Study Reports (clinical studies)

We are capable to prepare dossier for more than 90 countries.