Experience complete pre-and post-marketing drug safety surveillance as per global regulatory standards.       Highlights           Investigator/site training Medical safety monitoring Spontaneous adverse event reporting Periodic Safety Update reports (PSURs) and other pharmacovigilance documents Pre-FDA meeting briefing documents Regulatory dictionary coding–MedDRA, WHO, sponsor-specific Regulatory reporting Distribution of expedited safety reports to investigators/IRBs Interim safety listings and reports, i.e., project status monitoring, Data Safety Monitoring Boards(DSMBs) Annual reports to regulatory authorities Addressing safety issues in a comprehensive and precise manner