End to end services for various pharmacovigilance aggregate reports for more
than a decade across all regions including US, EU, Japan, China and other APAC countries.
Differentiators
GLOBAL PIONEER IN DSUR’S
First DSUR submitted by SIRO IN 2011, within 30 days of ICHE2F guideline implementation
Over 500 DSURs submitted with no queries from health authorities
CORE EXPERTS IN RISK MANAGEMENT PLAN
Specialized team for EU and Core RMP to leverage efficiencies in authoring, technical review and QC for all types of regulatory submissions
DEDICATED EXPERTS ACROSS ALL MAJOR THERAPEUTIC AREAS
Proficient across all major Therapeutic Areas, scientific review of aggregate reports by team of specialized physicians
Over 500 DSURs submitted with no queries from health authorities
INNOVATION
Day minus 90 implementation of aggregate reports
Document Types
