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Quality Assurance / Quality Control
Each facility is independently supported by Quality Assurance team to
Implement and maintain procedures and systems in compliance with Good Clinical Practice (GCP) and applicable regulatory requirements
To conduct study based, facility based, process based inspection/audits
To investigate the discrepancies and verify CAPA
To review and approve/ disapprove deviations and changes
To present organization in sponsor, regulatory inspection/audits
Corporate Quality Assurance and Regulatory
Each facility is independently supported by Corporate Quality Assurance and Regulatory team for
Ensuring system Harmonization across all location
Ensuring compliance to Quality through frequent system audits and check
Coordinate Employee Training in GCP and GLP on regular basis
Vendor Qualification
Preparation and compilation of Clinical Study Report as per ICH E3 guidance
CTD/eCTD submissions in compliance with regulatory requirements