Regulatory Support A critical aspect of our responsibility to our clients is to ensure compliance with the changing regulatory guidelines and requirements as well as adapting our services to the emerging trends in submission procedures and technologies. Sound academic qualifications and broad-based practical experience allows our personnel to undertake a variety of scientific review functions on behalf of our clients. Regulatory support includes (SAE) Serious Adverse Event Reporting Compliant with FDA, TPD and European Regulatory Guidelines. These services include the following: • Regulatory Support   - IND and NDA support at regulatory meetings   - Ensuring compliance with regulatory guidelines and regulations   - Support of NDAs and electronic submissions • Integrated Safety and Efficacy Databases   - Develop and manage database   - Compile all key patient data from ongoing studies for reporting • Serious Adverse Event Reporting   - Serious Adverse Event Report data capture – web based –      hosted by SciAn Services   - Report SAE – electronic and paper              Back to Services Overview Page              Download Corporate Brochure

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