QREC Regulatory submissions services are conducted by local experts with a knowledge base in national guidelines and procedures, key aspects of the local regulatory process and document management practices.
When making submissions, we believe it is of utmost importance that it be handled locally versus centrally. Only then can we guarantee the expertise required to minimize deficiency letters.
The key responsibilities are:
- Coordinating the Preparation, Translation and Review of documents needed for the submission packages. (including obtainment of HMSC clearence, study/country specific requirements, registration on National Clinical Trials Registry database, etc.)
- Overseeing submission of clinical trials to regulatory authorities and ethics committees according to SOPs, local legislation and client requirements
- Interacting with the authorities in regards to questions or needed follow-up
- Coordinating the review of amended materials
- Providing approvals to the clinical operations manager
- Archiving the submission packages and corresponding communications and approvals
QRECTM Clinical Research LLP
