Technical dossier

Ompi's Technical Dossiers are available to assist our clients for European and Worldwide Regulatory submissions.

The Technical dossiers (CTD form) contains relevant sections of packaging components information for the compilation of Module 3 Common Technical Document.

In order to facilitate the drug submissions worldwide we provide to our clients regulatory support from initial regulatory evaluation of Ompi products to final authority approval of drug evaluation, access to our DMFs at FDA and Health Canada through LOA release and Technical Dossiers.

For further information and Technical Dossier request, click here.