» Local Environment» Bulgarian Healthcare System» Regulatory framework» Approval of clinical trials» Services» Regulatory affairs» Feasibility» Clinical monitoring» Project management» Drug handling» Other services» Advantages» Contacts


Regulatory affairs

Our regulatory activities include regulatory submissions of applications for approval of clinical studies as well as submissions of SAE and SUSAR reports as per the local requirements. By having the knowledge of the local laws and regulations on clinical studies UniMR is able to streamline the regulatory approval process in the shortest time possible. We also provide certified translation of regulatory documents.


Home /  / Regulatory affairs
 © 2013 All rights reserved
 Bulgaria, Sofia
design and hosting:  
MAKSOFT, Sofia © 2013