Regulatory Affairs

At SOCAR, we understand the importance of submitting complete dossiers to the Competent Authorities and Ethics Committees. Submission of incomplete dossiers will lead to substantial delays in obtaining the final approvals which can not be recovered during the project life cycle.

SOCAR has 25 years experience with the preparation and submission of complete dossiers to the Competent Authorities and Ethics Committees. During the course of your research project, SOCAR can also prepare and submit protocol amendments, notifications and similar filings.

The regulatory services provided by SOCAR include:

Translation of documents as required
Application for EUdract number
Completion of CTA application
Collection and collation of all documents required for submission
Submission of complete dossiers
Follow-up of dossiers until final approval received
Preparation, submission and follow-up of substantial protocol amendments
End of study notifications
Regulatory Affairs
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