Regulatory Support - Stevanato Group
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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

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How can we help you?

Please submit your questions or inquiries here

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