Regulatory support

Services:

• Checking and verification of documents to be submitted to regulatory bodies;

• Obtaining patient insurances in clinical studies;

• Submission of documents to regulatory bodies for clinical trial approvals, further tracking of their status, responses on inquires prior getting approval on clinical trials;

• Obtaining import/export approvals;

• Regulatory support with expert assessment in each project;

• Submission and obtaining approval from local ethics committees of study sites;

• Submission of safety reports;

• Translations;