Regulatory services and Marketing authorization
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Regulatory consultancy.
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Submission package preparation.
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Submissions to Competent authorities and Ethics committees.
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Communication and issues resolution until the study approval.
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Marketing Authorization Applications (national and EU (MRP, DCP)).
- Post-approval license maintenance.
DOKUMEDS has developed an excellent collaboration with national Competent Authorities, Ethics Committees and key opinion leaders. The national know-how ensures our ability to handle country specific procedures complying with local laws and requirements.
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.
