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3. Regulatory Affairs
3. Regulatory Affairs The Administrative Unit of Delos Clinical is specializes in the processing of all kinds of observational studies and clinical trials. The experience of our CTA allows to expedite the authorization of study and medical devices.
1. Observational studies legal requirements
2. Clinical trial authorizations
3. Investigational Medicinal Product Dossiers
4. Ethical committee submission
5. Site contract, budget negotiation and grant administration
6. Processing of civil and corporate liability
7. Regulatory meeting briefing packages
8. Development Safety Update Reports
9. Complete and submit Annual Progress Report
10. Risk Management Plans
11. Pediatric Investigation Plans
12. Clinical study reports.
13. Manufacturing license application
14. European C.E. marking
15. Marketing studies
 
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Tags   cro   research   pre-clinical
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