ICSR management, being the most scientific and priory activities, needs multiple platforms trained team. COD provides complete ICSR management services via in-house/client hosting system.
As case processing is dynamic and resource driven, we do consider supporting client on all the following aspects:
Case Intake and Processing Services
Scheduling
Authoring
SME Review
Submission
Specialized Aggregate Reports Services
Submission of RFI and PRAC assessment Report
Line listings Review
Regulatory Website review & tracking of PSUR report
Publishing of Report
MAH System Support
GAP Analysis/Audit
Oversight System Setup
Workshop/Training