OUR GROUP OUR OFFER INNOVATION CAREERS PR & EVENTS CONTACT US Language 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. Write us for any information or particular need→ 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 ... Analytical Solutions Aimed at guaranteeing the integrity of parenteral medicines DISCOVER→ EZ-fill® Platform A fully integrated ready-to-use solution for your aseptic manufacturing DISCOVER→ Add-on components Ompi Add-On Components range includes rubber plungers, backstops, plunger rods, customized plastic features, needles and safety devices DISCOVER→ How can we help you? Please submit your questions or inquiries here CONTACT US → OUR OFFER Pharmaceutical Systems Engineering Systems CAREERS Job opportunities Life at Stevanato Group Schools & Universities FOLLOW US Website language IT EN Privacy policy Cookie Policy Legals Purchasing & Sales Conditions © Stevanato Group 2018