Regulatory Support - Stevanato Group
search img
Logo Stevanato Group

In order to facilitate the drug submissions worldwide Ompi Regulatory Affairs (RA) provides to customers regulatory support for the initial regulatory assessment of Ompi products and continuous support during authority approval of drug dossiers. Ompi RA provides access to DMFs filled or registered at FDA and Health Canada through LOA release and supply customers with Technical Dossiers for submissions in Countries where DMFs are not available.

On the following link LOA request form you may request the LETTER OF AUTHORIZATION for your drug submission in USA and Canada.

For further information or any particular need about our Regulatory Services, please contact us clicking here

LoA Request Form
Letter of Authorization for Master Files
Click here
Technical Dossiers
to assist our clients for European and Worldwide Regulatory submissions
Click here
Regulatory Affairs Contact Center
For further information or any particular need about our Regulatory Services, please contact us
Click here

You might also be interested in ...

img
Analytical Solutions

Aimed at guaranteeing the integrity of parenteral medicines

img
EZ-fill® Platform

A fully integrated ready-to-use solution for your aseptic manufacturing

img
Add-on components

Ompi Add-On Components range includes rubber plungers, backstops, plunger rods, customized plastic features, needles and safety devices

How can we help you?


Please submit your questions or inquiries here


CONTACT US
logo stevanato group
FOLLOW US
linkedin facebook