Regulatory services and Marketing authorization

Range of regulatory services provided by DOKUMEDS includes both regulatory activities for clinical trials and services related to the product authorization and market maintenance.

• Marketing Authorization Applications (national and EU)
• Clinical trials applications
• Submission package preparation
• Ethics committee(s) and Regulatory submissions followed by communication and issues resolution until the study approval
• Authorization maintenance and support

DOKUMEDS services are especially focused on regulatory consultancy and marketing authorization handling in Ukraine and Russia where clinical trials are being considered as part of marketing approval.