Regulatory support

We are fully committed to be the best, objective-focused partner in the research and delivery of innovative solutions to support the success of our customers.

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 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