Aimed at guaranteeing the integrity of parenteral medicines
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.
Ompi Add-On Components range includes rubber plungers, backstops, plunger rods, customized plastic features, needles and safety devices
