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 and such delays can never be recuperated during the project life cycle.
SOCAR has a vast experience with the preparation and submission of complete dossiers to the competent
authorities and Ethics Committees. During the research project, SOCAR can also prepare and submit
substantial protocol amendments, notifications and so on.
The regulatory services provided by SOCAR include:
- Translation of documents as required
- Application for EUdract number
- Completion of CTA application form
- 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 collation
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