Regulatory affairs

CROPRIME offers regulatory consulting.

 

Many years of experience, working with the professional team make us perfect in every day duties.

 

We prepare an effective strategy related to regulatory activities in all European locations.

 

Apart from EC and FDA submissions we also offer sworn translation services of country specific documents.

 

 

We provide electronic submissions as well as regulatory due diligence, FDA submissions.

 

All services are based on Europe’s Clinical Trial Directive.